Patients should have no contraindications to having a contrast enhanced MRI scan; these contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice
Increased intracranial pressure or other contraindications to internal or external jugular venous compression.
Lack of contraindications to systemic immunotherapy (see list of exclusions below)
Patients with anticipated contraindications to interval tumor reductive surgery
Is ineligible for an operation based on medical or oncologic contraindications to surgery
Any contraindications to MRI (eg, participants with pacemakers, claustrophobia, excessive weight, etc).
Known contraindications to radiotherapy
Medical contraindications to thoracic irradiation
Patients are known to have contraindications to radiotherapy
Have known contraindications or sensitivities to the study drug
No contraindications to the study medications or uncontrolled medical illness
PHASE II: No contraindications to MRI
Contraindications to MRI, including claustrophobia, metallic implants, and pacemakers
Contraindications for transdermal nicotine patch therapy (TNP)
For Part I: patients with known contraindications to platinum agents are excluded
Contraindications to treatment with:
Medical oncology examination to evaluate medical contraindications prior to start chemotherapy
Have contraindications to receiving doxorubicin hydrochloride (HCl).
Subjects who have contraindications to carboplatin, melphalan, etoposide phosphate, or sodium thiosulfate
Subjects who have contraindications to carboplatin, cyclophosphamide, etoposide phosphate, or sodium thiosulfate
No contraindications to protocol chemotherapy.
Any contraindications for ipilimumab (Yervoy®) or nivolumab (Opdivo®) as per the package inserts.
Contraindications to MRI such as non-MRI-compatible implanted devices
mCRC currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Subjects who have contraindications to carboplatin, melphalan, or STS
Contraindications to radiation
No contraindications to breast MRI
Medical contraindications to esophagectomy
Any contraindications to pegylated or non-pegylated interferon
Any contraindications to pegylated interferon or hydroxyurea
Allergy or contraindications to administration of the GI anti-spasmodic drug:
Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening
Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing magnetic resonance (MR) scanning
Contraindications for doxorubicin administration
MRI contraindications.
Known contraindications to radiotherapy
Contraindications to administration of bortezomib
Contraindications to seed placement, including uncontrollable bleeding diathesis
E 18. Contraindications to the use of corticosteroid treatment.
Any contraindications to irradiation
Patients with contraindications to surgery;
Contraindications for doxorubicin administration.
Any medical contraindications for chemotherapy
Contraindications to the use of corticosteroid treatment.
Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Contraindications to steroid use
Locally advanced basal cell carcinoma lesion that is considered to be inoperable or to have medical contraindications to surgery
Patients with a malignancy that is currently not amenable to surgical intervention, due to either medical contraindications or non-resectability of the tumor.
Subjects with contraindications to all of the designated comparator drugs
No known contraindications to intended therapies
Have contraindications for NRT
Known contraindications to peripheral nerve block placement
Contraindications to exercise
Major contraindications to anamorelin e.g. hypersensitivity
In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
Standard general contraindications to ERCP or PTBD (e.g. hemodynamic instability, uncorrected coagulopathy).
Absolute contraindications by pulmonary function testing
In the opinion of the surgeon, the subject has no medical contraindications to distal pancreatectomy
In the opinion of the surgeon, the subject has medical contraindications to distal pancreatectomy
No contraindications to undergo MRI
Contraindications to MRI
Patients should have no contraindications to having a contrast enhanced MRI scan; these contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department
Patients with contraindications to MRI will not be enrolled
Medical contraindications to blood draw (e.g., hemophilia)
Contraindications to NRT
Medical contraindications for NRT
Contraindications to MRI 2.1 Claustrophobia 2.2 Implanted ferromagnetic materials or foreign objects 2.3 Known intolerance to the MRI contrast agent
Subject has contraindications for radiation
Patients with contraindications to CEUS
Patients with contraindications to both CT and MRI
Has known contraindications to MRI
Subjects with contraindications to MRI
With contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
HEALTHY CONTROLS: No contraindications for MR or PET imaging
GYNECOLOGIC CANCER: No contraindications for MR or PET imaging
Patients with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI
Subjects with contraindications to the use of [18F] FAZA including confirmed allergy.
Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
Contraindications for MRI or GBCA (standard of care)
Patients with contraindications to MR
No contraindications to getting contrast enhanced MRI examinations
Patients with contraindications for MRI due to embedded foreign metallic objects; bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
Contraindications to undergo MRI
Patient has no contraindications to the MRI
Contraindications for MRI (e.g. cardiac pacemaker)
Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
Patients with contraindications for MRI
Medical contraindications to esophagectomy
No obvious contraindications for primary chemotherapy
Contraindications to TRUS prostrate biopsy
Participant must not have any contraindications to MRI scanning
Patient must not have any medical contraindications to MRI (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis)
Contraindications for MRI
Patients should have no contraindications to having a contrast enhanced MRI scan; these contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Radiology Department
Contraindications for MRI
Subjects with contraindications to MRI
Does not meet any standard contraindications for MRI (such as being claustrophobic, having metal objects within the body that cannot be removed or having large tattoos), confirmed by completion of our clinical MRI questionnaire form
Contraindications for surgery
MRI contraindications include: \r\n* Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips  \r\n* Patients with implanted pacemaker or implanted defibrillator device \r\n* Patients with contraindications for MRI due to embedded foreign metallic objects; bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient  \r\n* Implanted medical device not described above that is not MRI-compatible \r\n* Known history of claustrophobia \r\n* Contrast contraindications not included since patients will not be receiving MRI or CT contrast as part of this study
Contraindications to fMRI, including severe claustrophobia, presence of tissue expanders for breast reconstruction, and presence of a port-a-cath that is incompatible with MRI
No contraindications for e-cigarette use
Participants with standard contraindications to non-contrast MRI will be excluded, including claustrophobia and metallic implants incompatible with MRI
Patients with contraindications to having a contrast enhanced MRI scan
no FDA contraindications for use of NRT:
Contraindication to MRI\r\n* Cardiac pacemaker or defibrillator\r\n* Surgically implanted electrical devices such as spinal stimulation devices or intracranial stimulation devices, cochlear implants, the presence of metallic foreign bodies in the orbits, and incompatible old mechanical heart valves and aneurysm clips
Have septal aneurysm or other heart aneurysm.
Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded
Patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded
Patients who are not suitable to undergo MRI or use gadolinium contrast due to:\r\n* Claustrophobia\r\n* Presence of metallic objects or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n* Sickle cell disease\r\n* Renal failure\r\n* Reduced renal function, as determined by creatinine clearance < 30 mL/min based on a serum creatinine level obtained within 28 days prior to registration
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
Ferromagnetic objects such as jewelry or metal clips in clothing
For patients with localized prostate cancer contraindication to MRI:\r\n* Patients weighing > 136 kilograms (weight limit for the scanner tables)\r\n* Allergy to MR contrast agent\r\n* Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices
Patients unable to undergo MRI exams (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses [e.g. pins in artificial joints and surgical pins/clips], or unable to receive gadolinium for MRI, as per the standard UM Department of Radiology MRI screening criteria)
Patients who cannot undergo magnetic resonance imaging (MRI) or single photon emission computed tomography (SPECT) for any reason including due to obesity or to having certain metal in their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates)
Metal in the body (except dental fillings) e.g., pacemaker, infusion pump, metal aneurysm clip, metal prosthesis, joint, rod or plate.
MRI MONITORING SUB-STUDY: Implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants
Patients with one or more of the following contraindications for MRI and/or MRI contrast agents such as:\r\n* Severe claustrophobia\r\n* Aversion to MRI\r\n* Metallic fragments, clips or devices in the brain, eye, and/or spinal canal in which movement in the bore of the magnet may damage sensitive tissues, unless deemed to be safe by the manufacturer; note: metallic fragments, clips or devices outside the brain, eye, and/or spinal canal may be safe if deemed by the manufacturer; caution is needed to determine safety for each patient that may have the following conditions: cardiac pacemaker; heart valve replacement, venous umbrella, being a sheet-metal worker or welder; aneurysm surgery, renal or aortic clips, prosthetic devices such as middle ear, eye, joint, or penile implants, joint replacement, hearing aid, neurostimulator, insulin pump, intrauterine devices (IUD), shunts/stents/metal mesh/coil implants, metal plate/pin/screw/wires, or any other metal implants, and permanent eyeliner and/or eyebrows
Standard contraindications to MRI: for example, MRI non-compatible cardiac pacemakers, intracranial clips, foreign metal objects in the body and others as defined in the University of Texas (UT) Southwestern Institutional MRI Safety Policy
Patients with pacemakers, ferro-magnetic aneurysm clips, metal infusion pumps, metal or shrapnel fragments or certain types of stents
Known contraindication to enhanced MRI and computed tomography (CT), including but not limited to:\r\n* Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel\r\n* History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine
Clips or other metallic implanted objects in the skull or the brain, except shunts.
Intracranial aneurysm clips (except Sugita) or other metallic objects
Presence of metallic objects such as artificial joints, inner ear (cochlear) implants, brain aneurysm clips, pacemakers, and metallic foreign bodies in the eye or other body areas that would prevent use of MRI imaging
Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects
Patients not suitable for cardiac MRI; contraindications include:\r\n* Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices\r\n* Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal\r\n* Allergy to gadolinium or other severe drug allergies\r\n* Claustrophobia\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV)\r\n* Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy
Patients who cannot undergo MRI or single-photon emission computed tomography (SPECT) due to obesity or to having certain metal in their bodies (specifically pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates)
Patients with pacemakers or any metallic objects as exclusion for MRI
Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
Conditions that would preclude from successfully scanning subjects in magnetic resonance imaging (MRI):\r\n* Claustrophobia (this would make lying in the scanner very uncomfortable)\r\n* Having a pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants\r\n* History of seizures\r\n* History of head injuries resulting in loss of consciousness > 10 minutes
Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
EXCLUSION - PATIENT: Presence of MRI unsafe devices or objects which would make having an MRI unsafe, as per institutional clinical protocol. MRI unsafe devices or objects for the purposes of exclusion include but are not limited to certain intracranial aneurysm clips, cardiac pacemaker, and implantable defibrillator devices, metallic heart valve, or coronary artery stents, breast tissue expanders, bio or neurostimulators, pellets and bullets, ocular implants and devices, otologic and cochlear implants; other devices or metallic objects may be deemed unsafe for MRI at the radiologist’s discretion
Participants with intracranial clips, metal implants or external clips within 10 mm of the head
Women with aneurysm clips that don't allow for MRI
Those with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices
CONTROL (HEALTHY) GROUP: Those with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
Risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
Risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
Suitable to undergo MRI and receive the contrast agent gadolinium (exclusions follow):\r\n* No history of untreatable claustrophobia\r\n* No presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n* No history of sickle cell disease\r\n* No contraindication to intravenous contrast administration\r\n* No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); patient may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance\r\n* No findings consistent with renal failure, as determined by glomerular filtration rate (GFR) < 30\r\nmL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to registration\r\n* Weight lower than that allowable by the MRI table
Presence of non magnetic resonance (MR) compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
Patients with a metal heart valve, surgical clips, a pacemaker or any other indwelling metal device that might interfere with MRI
Patients with a metal heart valve, surgical clips, a pacemaker or any other indwelling metal device that might interfere with MRI
Patients who are not suitable to undergo MRI or PET or use gadolinium contrast due to:\r\n* Claustrophobia\r\n* Presence of metallic objects or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants); the craniotomy patients will all have titanium but this is MRI compatible\r\n* Sickle cell disease\r\n* Renal failure\r\n* Reduced renal function, as determined by creatinine clearance < 30 mL/min based on a serum creatinine level obtained within 28 days prior to registration
Patients with contra-indications for contrast enhanced magnetic resonance (MR) exam, including:\r\n* Cardiac pacemaker or pacemaker wiring in situ\r\n* Cerebral clips or metal artificial cardiac valves\r\n* Ossicle prosthesis\r\n* Conditions that could produce a dangerous situation in the presence of a strong magnetic field: line metallic implants, shrapnel, inability to lie still, and conditions that can worsen inside confined spaces (severe claustrophobia, psychosis)\r\n* Acute or chronic severe renal disease as determined by glomerular filtration rate (GFR) < 30 ml/min/1.73 m^2\r\n* Pregnancy or breastfeeding
Subjects with any type of pacemaker, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
Patients who are not suitable to undergo MRI or use gadolinium contrast due to:\r\n* Claustrophobia\r\n* Presence of metallic objects or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n* Sickle cell disease\r\n* Renal failure\r\n* Reduced renal function, as determined by creatinine clearance < 30 mL/min based on a serum creatinine level obtained within 28 days prior to registration
Any contraindication to undergoing MRI (e.g., pacemakers, cochlear implants, shrapnel injuries, or other types of metal or electric devices in the body, severe claustrophobia, cataract surgery with certain ocular implants [the following ocular implant models from Bausch & Lomb are considered unsafe for MRI: intraocular lens, models 12A, 12P, 12S, 24P, 31P, 42P, 61P, 71, 71B, 71M, 71P, 71PC, 71R, 75M, 75P, EXP D])
Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: \r\n* Electronically, magnetically, and mechanically activated implants\r\n* Ferromagnetic or electronically operated active devices · metallic splinters in the eye\r\n* Ferromagnetic hemostatic clips in the central nervous system (CNS) or body\r\n* Cochlear implants\r\n* Other pacemakers\r\n* Insulin pumps and nerve stimulators\r\n* Non-MR safe lead wires · prosthetic heart valves (if dehiscence is suspected)\r\n* Non ferromagnetic stapedial implants\r\n* Pregnancy\r\n* Claustrophobia that does not readily respond to oral medication
No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
Contraindication to MRI (i.e. pacemakers, aneurysm clips, or shrapnel fragments)
Have non-MRI compatible metallic objects on/in body
Presence of MRI-incompatible metallic objects or implanted medical devices in the body (including but not limited to: non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, metal fragments in the eye or central nervous system)
Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
Patients unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips
Patients unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips
Patients with a pacemaker, stainless steel aneurysm clip or any other magnetic resonance (MR) contraindicated implant or foreign body would warrant exclusion from this study; pacemakers may be reprogrammed or turned off by the strong MRI magnetic field; radio-frequency (RF) fields in MR can also cause severe heating of pacemaker lead tips. Steel aneurysm clips are prone to torque in the strong MR field which can displace the clips and may damage the vessel, resulting in hemorrhage, and/or death
Patients who are no suitable to undergo MRI or use gadolinium contrast due to:\r\n* Claustrophobia\r\n* Presence of metallic objects or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n* Sickle cell disease\r\n* Renal failure\r\n* Reduced renal function, as determined by creatinine clearance < 30 mL/min based on a serum creatinine level obtained within 28 days prior to registration
Have any contra-indications to magnetic resonance (MR) examination such as allergy to MRI contrast media (gadolinium-DTPA [gadopentetate dimeglumine]), metallic foreign objects within the body, orbital metal, cerebral aneurysm clip, pacemaker, defibrillator, neurostimulator, any other medical metallic implant, claustrophobia, inability to lie flat for 30 minutes, and weight exceeding 300 pounds; if an MR contraindication is discovered during scanning that was overlooked during the screening process, the procedure will be stopped immediately and the subject will be removed from the scanner
Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non-MRI compatible surgical clips, shrapnel; pregnant or breast-feeding women are excluded
Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants
Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants
Subjects who are unable to tolerate or are not eligible for MR imaging (claustrophobia, metal implantable devices such as pacemaker, aneurysm clips, etc)
Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips
Contraindication to MRI:\r\n* Patients weighing more than weight limit for the scanner tables\r\n* Allergy to magnetic resonance (MR) contrast agent\r\n* Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device
Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient
Contraindication to MRI scanning, such as surgery that involves metal clips or wires or metal prostheses which might be expected to cause tissue damage or produce image artifacts
Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
Contra-indications to MRI and/or PET/MRI:\r\n* Electrical implants such as cardiac pacemakers or perfusion pumps\r\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants\r\n* Ferromagnetic objects such as jewelry or metal clips in clothing\r\n* Pregnant subjects\r\n* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI)
Patients unable to undergo magnetic resonance (MR) exams are not eligible (i.e. patients with non?compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses, pins in artificial joints and surgical pins/clips)
Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
Subjects that have vascular or aneurysm clips, or metallic staples from a surgical procedure
Aneurysmal clips
Any patient with a metallic MRI incompatible implant, including cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, cochlear implants or ferrous surgical clips
Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
surgical clips or other metallic implants;
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing
Non-removable hearing aid or dentures, metal intrauterine device (IUD), surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates or screws, surgery leaving implanted materials, metal injury to eye, metallic tattoos anywhere on the body, tattoos near the eye and transdermal patches
Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
Ferromagnetic objects such as jewelry or metal clips in clothing
Patients who are claustrophobic or have other contraindications to MRI, such as implanted pacemaker device vascular clips, surgical clips, prosthetic valves, pacemakers, otologic implants
Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
Normal MRI exclusion criteria will apply, including those on the following list; a standard MRI safety form will be used to identify potential conditions warranting exclusion\r\n* Electrical implants such as cardiac pacemakers or perfusion pumps\r\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants\r\n* Ferromagnetic objects such as jewelry or metal clips in clothing\r\n* Claustrophobia\r\n* History of seizures\r\n* Diabetes
Patients who have presence of a known contraindication to MRI\r\n* Pacemaker\r\n* Aneurysmal clips\r\n* Metal implants in field of view \r\n* Pregnant\r\n* Age and mental status wherein he/she is unable to cooperate for MRI study
Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc
The standard exclusion criteria for MRI exams will apply which include patients with pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and severe claustrophobia
All patients who are contraindicated for MR imaging in general; contraindications include:\r\n* Electrical implants such as cardiac pacemakers or perfusion pumps\r\n* Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants\r\n* Ferromagnetic objects such as jewelry or metal clips in clothing\r\n* Pregnant subjects\r\n* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest.
Inability to undergo MRI with gadolinium contrast or PET imaging due to:\r\n* Claustrophobia\r\n* Presence of metallic objects or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)\r\n* Sickle cell disease\r\n* Renal failure\r\n* Reduced renal function, as determined by creatinine clearance < 30 mL/min based on a serum creatinine level obtained within 28 days prior to registration
Have permanently implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants
Patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study
Not suitable to undergo MRI or gadolinium-based contrast agent because of:            \r\n* Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice\r\n* Presence of MRI-incompatible metallic objects or implanted medical devices in body (including, but not limited to: non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, or metal fragments in the eye or central nervous system)\r\n* Renal failure, as determined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m^2 based on a serum creatinine level obtained within 48 hours prior to enrollment\r\n* Weight greater than that allowable by the MRI table, per local institutional practice
Contraindications to MRI\r\n* Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips\r\n* The presence of an implanted pacemaker or implanted defibrillator device\r\n* Patients with contraindications for MRI due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient\r\n* Implanted medical device not described above that is not MRI-compatible\r\n* Known history of claustrophobia
Patients who are contraindicated for MRI or gadolinium contrast agents due to:\r\n* Claustrophobia\r\n* Presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, skin staples, implanted prostheses, artificial heart valves with steel parts, metal fragments, shrapnel, or other metal implants that would contraindicate MRI)\r\n* Sickle cell disease\r\n* Renal failure with estimated GFR < 30 mL/min/1.73 m^2 based upon serum creatinine\r\n* Weight greater than 350 pounds (lbs) (the weight limit for the MRI)
Subjects who have any type of biomedical implant, device and/or ferromagnetic material that can be displaced, perturbed, or otherwise malfunction due to mechanical, electronic, or magnetic means; these items may include:\r\n* Metallic fragments or shrapnel (such as from war wounds)\r\n* Cerebral aneurysm clips, biopsy marker clips\r\n* Vascular access ports (as are used with intravenous chemotherapy)\r\n* Cochlear implants, pacemakers, neurostimulators, biostimulators, and electronic infusion pumps\r\n**Implanted materials other than those verified as being rated “magnetic resonance [MR] Safe” or “MR Conditional 6” will not be allowed on study
Patients who have cerebral aneurysm clips
Subjects who have cerebral aneurysm clips
Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin of body that would preclude obtaining an MRI as part of the initial study evaluation
Women with MRI/magnetic resonance angiogram (MRA) contraindications such as a cardiac pacemaker, aneurysm clip, cochlear implants, and metal in the eyes
Contraindications for MRI (such as claustrophobia, pacemaker, non MR-compatible artificial heart valves, cochlear implants, surgical clips in the brain, metal fragments in eye)
Braces or metal heart valves that may interfere with MRI, surgical clips, a pacemaker, piercings that cannot be removed, or any other indwelling metal device that might interfere with MRI
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Sexually active men and women of child-bearing potential must use highly effective contraceptives (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 30 days after the last dose of study drug for females and 90 days for males. If a female subject or the partner of a male subject becomes pregnant, the sponsor must be notified. Male subjects should refrain from sperm donation for 90 days after the last dose of study drug
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g., such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Patient with reproductive potential who will not agree to use, during the study and for 60 days after the last dose of PF-05082566 or 6 months for T-DM1 or trastuzumab two highly effective method of contraceptive such as implants, injectables, intrauterine devices (IUDs) such as copper T or levonorgestrel-releasing intrauterine system (LNG-IUS), sexual abstinence, vasectomized partner, or condom or occlusive cap (diaphragm or cervical/vault cap) supplemented with the use of a spermicide during treatment
Female patients must not be pregnant or breast-feeding; female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 6 months following the last administration of trial drug(s); female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to starting stereotactic radiosurgery (SRS)
Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 6 months following the last administration of trial drugs
Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. OR Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for >=1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
Male and female subjects who agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence , or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy; female patients of reproductive potential who are not surgically sterile must practice adequate birth control for a minimum of twelve months post-treatment; male patients who are not surgically sterile must practice adequate birth control for a minimum of three months post-treatment
Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during and after the trial
Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-human chorionic gonadotropin [hCG]) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use both a highly effective method of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal (defined as absence of menses for >= 1 year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for 30 days following the last dose of study drug
Male and female subjects must agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Male and female subjects who agree to use both a highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (e.g. condoms, vaginal ring, sponge, etc) during the period of therapy and for 90 days after the last dose of study drug
Male and female subjects must agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectable, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Male and female subjects who agree to use both a highly effective methods of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g., condoms, cervical ring, sponge, etc.) during the period of therapy and for 30 days after the last dose of study drug
Fertile male patients must agree to use a highly effective contraceptive method (i.e., with a failure rate of < 1 % per year, such as vasectomy, sexual abstinence, or female partner's use of hormonal implants or combined oral contraceptives) during the trial and for a period of at least 6 months after the last dose of study drug
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Female participants of childbearing potential should ensure use of a highly effective method of birth control as defined by the investigator, for example, those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectable, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner during the study and for a period of at least 4 months following the last dose of any drug administered during the study
Male and female patients must agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Patients who are sexually active, with preserved reproductive capacity, and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Patients who are sexually active and unwilling to use a medically acceptable method of contraception, e.g. condom plus spermicide use for participating males, plus another form of birth control such as implants, injectables, combined oral contraceptives, intrauterine devices for female partners, during the trial and for at least three months after end of active therapy. Men unwilling to agree to not donate sperm while on trial drug and up to 6 months following the last dose of trial drug.
Patients of childbearing potential must be willing to practice highly effective birth control (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the study and for 30 days after the last dose of study drug; women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal
Patients who are sexually active and unwilling to use a medically acceptable method of contraception (e.g. such as implants, injectables, combined oral contraceptives, some intrauterine devices or vasectomized partner for participating females, condoms for participating males) during the trial and for at least three months after end of active therapy
Female patients must not be pregnant or breast-feeding; female patients of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile) must use a highly effective contraceptive method (allowed methods of birth control, [i.e. with a failure rate of < 1% per year] are implants, injectables, combined oral contraceptives, intra-uterine device [IUD; only hormonal], sexual abstinence or vasectomized partner) during the trial and for a period of > 6 months following the last administration of trial drug(s); female patients with an intact uterus (unless amenorrhea for the last 24 months) must have a negative serum pregnancy test within 48 hours prior to first study procedure (leukapheresis)
Fertile male patients must agree to use a highly effective contraceptive method (allowed methods of birth control [i.e. with a failure rate of < 1% per year] include a female partner using implants, injectables, combined oral contraceptives, IUDs [only hormonal], sexual abstinence or prior vasectomy) during the trial and for a period of > 6 months following the last administration of trial drugs
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; female patients who are of non-reproductive potential include the following: post-menopausal by history - no menses for >= 1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy); female patients of childbearing potential must have a negative serum pregnancy test upon study entry; male and female patients who agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug
Male and female subjects who agree to use highly effective methods of birth control (e.g., implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (e.g., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days (females) and 90 days (males) after the last dose of study drug
Male and female subjects of reproductive potential agree to use highly effective methods of birth control (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) during the period of therapy and for 90 days after the last dose of study drug.
Female subjects of child-bearing potential who are unwilling to use highly effective contraception (e.g., combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives, intrauterine devices, bilateral tubal ligation, vasectomized partner, sexual abstinence or equivalent measures) for the duration of study treatment
Male and female subjects who agree to use highly effective methods of birth control (eg, condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) during the period of therapy and for 30 days after the last dose of study drug
Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], sexual abstinence, or sterilized partner) and a barrier method (eg, condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days after the last dose of the study drug for males
11. Male or female fertile patient using reliable contraceptive measures (such measures, for patient and sexual partner, include: implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized/sterilized partner, use of a double-barrier method or sexual abstinence). The patient and his/her parent(s)/legal guardians must be counseled on the importance of avoiding pregnancy before or during the study.
Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study; sexually active men and women of child-bearing potential must use highly effective contraceptives (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 30 days after the last dose of study drug for females and 90 days for males; if a female subject or the partner of a male subject becomes pregnant, the sponsor must be notified; male subjects should refrain from sperm donation for 90 days after the last dose of study drug
Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps
Implanted pacemaker, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain or other documented clinically significant arrhythmias
Implantable electronic medical devices in the brain
Patients with active implanted medical device, a skull defect (such as, missing bone with no replacement), a shunt or bullet fragments; examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts
Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
Have implanted cardiac pacemakers or defibrillators
Have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
Implantable electronic device in the brain
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)).
Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
Implanted with heart pacemaker or other implanted electronic device
Contraindications to MR imaging (e.g. implanted metallic prostheses, defibrillators, stimulators, pacemakers, or neurotransmitters) per institutional policy on management of patients with internal and external medical devices.
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord.
Patients with a contraindication to MRI such as implanted metal devices or foreign bodies or severe claustrophobia
Implanted hardware which limits treatment planning or delivery (determined by the investigator)
Patients with electronic pacemakers or defibrillators.
The patient has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant[s]); NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants and venous access devices (e.g. Port-a-Cath or Mediport) are permitted; the study chair must be contacted prior to consenting any subject who has any other device and/or implant
Patients with active implanted medical or electronic device or bullet fragments including pacemakers, defibrillators, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, and programmable shunts
Patients with active implanted electronic devices in the brain or spinal cord such as programmable VP shunts, deep brain stimulators, vagus nerve stimulators, are not allowed
Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices)
Prior history of hip, pelvic, or lumbosacral prosthesis or other implanted device
Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-MR conditional heart valves
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
Fewer than two acceptable sites exist for intramuscular (IM) injection and electroporation (EP) between the deltoid and lateral quadriceps muscles. Note: a site for injection/EP is not acceptable if there are tattoos or scars within 2 cm of the proposed injection/EP site or if there is implanted metal within the same limb. Any device implanted in the chest (e.g. cardiac pacemaker or defibrillator) excludes the use of the deltoid muscle on the same side of the body.
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant
The subject has an implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
Has implanted medical devices that pose high risks for colonization and cannot be easily removed
Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g. artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g. Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.
Implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs. Other common devices such as venous access devices (e.g., Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants that were placed more than 3 months prior to first dose of study drug.
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.
Implanted device or apparatus which obstruct visibility of the implanted sources on fluoroscopy
Patients with electronic pacemakers or defibrillators are excluded from this study, as the effect of electroporation on these devices is unknown; patients with lower extremity lesions may be discussed with the medical monitor
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.
Subjects who have implanted medical devices that pose high risks for colonization and cannot be easily removed (e.g., artificial heart valves, pacemakers, prosthetic joints, orthopedic screw(s), metal plate(s)) if infection occurs; other common devices such as venous access devices (e.g., Port-a-Cath or Mediport) may be permitted as well as arterial and venous stents and dental and breast implants
Has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)). NOTE: More common devices and prosthetics which include arterial and venous stents, dental and breast implants, and venous access devices (e.g., Port-a-Cath or Mediport) are permitted. Sponsor must be contacted prior to consenting any subject who has any other device and/or implant.
Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator, or vagus nerve stimulator, or documented significant arrhythmia at the discretion of the investigator
Patients with Gliadel bis-chloroethylnitrosourea (BCNU) implanted wafers will be excluded
Patient has implanted medical device(s) that pose a high risk for colonization and/or cannot be easily removed (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopedic screw(s), metal plate(s), bone graft(s), or other exogenous implant(s)); NOTE: more common devices and prosthetics which include arterial and venous stents, dental and breast implants and venous access devices (e.g., Port-a-Cath or Mediport) are permitted; sponsor must be contacted prior to consenting any subject who has any other device and/or implant
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts)
Patients with electronic pacemakers or defibrillators are excluded.
Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc.
Implanted electronic medical device in the brain:
Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts), a skull defect (such as missing bone with no replacement), a shunt, or bullet fragments
Tattoos or scars within 2 cm of the intended site of injection or if there is implanted metal within the same limb. Any device implanted in the chest (e.g., cardiac pacemaker or defibrillator) excludes the use of the deltoid muscle on the same side of the body;
Prior liver or heart transplantation or implanted cardiac mechanical assist device.
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord
MRI ineligibility due to the presence of a cardiac pacemaker, defibrillator or other implanted metallic or electronic device which is considered MR unsafe, severe claustrophobia or inability to lie flat for the duration of the study, etc.
Patients with electronic pacemakers or defibrillators are excluded from this study
Use of venous access devices made of materials other than silicone for the infusion of ganetespib; patients with these devices are eligible as long as the device is not used for the infusion
Have any active implanted electronic device (e.g., pacemaker),
Have an implanted electronically charged medical device
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
implanted devices that cannot be easily removed
Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain.
Cardiac pacemaker or other implanted electronic devices
As per self-report participants with pacemakers, intracranial electrodes, implanted defibrillators or any other prosthesis
Patients with only totally implanted CVCs or ports are ineligible
Existing implantable medical electronic devices, life-supporting medical devices, and medical monitoring devices \r\n* Note: metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices
No implanted medical devices or implanted metal in the head
Pacemaker or other electronic implanted device
Patients with cardiac pacemakers or other implanted electronic devices
Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
Has an implanted electronically charged medical device
Pacemaker or other implanted device
Active implanted medical device (e.g., cardiac pacemakers, defibrillators) or patients connected to electronic life support devices or metallic devices that would interfere with BIS measurements.
Have a pacemaker or implanted device.
No contraindications to the performance of a magnetic resonance study:\r\n* The presence of an implanted metallic object such as a cardiac pacemaker or implantable\r\ndefibrillator\r\n* An implanted neural stimulator\r\n* Any ferromagnetic implants not deemed MRI-safe\r\n* Intra-ocular metallic foreign bodies\r\n* Severe claustrophobia\r\n* Pregnancy\r\n* Inability to perform an exercise test
No implanted metallic objects
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
Presence of an implanted device that is incompatible with CT scanning
Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
Patients with pacemakers or other implanted magnetic devices that may malfunction or move in the strong magnetic field
Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
have implanted prosthetic heart valve,
Subjects who have vascular access ports or other implanted devices rated as anything other than “safe” or “conditional 6”
MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
Participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo MRI examination
Subjects with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)
Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction
Subjects who have vascular access ports or other implanted devices rated as anything other than “Safe” or “Conditional 6”
Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effect of the Calypso System operation on these devices is unknown.
Current use of any implanted electronic stimulation device
Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion
Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Varian Medical considers will interfere with the Calypso System's electromagnetic localization
Contraindication to MRI (metal implants)
Radiotherapy must begin within 12 weeks of last surgery (breast or axilla) or last chemotherapy\r\n* Note: Breast implants and expanders allowed
Patient with breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
Electrical implants such as cardiac pacemakers or perfusion pumps
Prosthetic implants in the pelvic region that contain metal materials (e.g., an artificial hip)
Breast implants; (patients who have implants removed are eligible)
Inner ear implants
Implants in the operated breast.
Presence of breast implants
Willingness and ability to schedule mastectomy 21-28 days following start of study agent; women with breast implants may participate
Breast implants (patients who have had implants removed are eligible)
Patients with breast implants are excluded.
Patients with metal implants less than 5 cm from the treatment
Implants in the operated breast
Undergoing bilateral mastectomy reconstruction with tissue expanders (ipsilateral therapeutic/contralateral prophylactic) planned to be exchanged for breast implants
Subjects with breast implants or a history of prior breast implants
Metal implants for the treatment extremity
History of a medical condition or procedure that is contraindicated for fMRI scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and
For local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants
Patient has metal implants near the surgical site that preclude treatment with the microwave system
Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).
Patients must not currently have breast enhancements (e.g., implants or injections)
EXCLUSION - PATIENT: Breast implants (silicone or saline)
Women with implants
Imaging sets with implants
Breast implants
Women with bilateral breast implants or tram flap reconstruction
Patients with breast implants
Women with breast implants
Bilateral breast implants or autologous breast flap reconstruction
Metal implants on same limb as intended administration site
Women with bilateral breast implants or tram flap reconstruction
Bilateral breast implants
Subjects with breast implants
Bilateral breast implants. Prior breast reduction surgery is allowed.
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
Bilateral breast implants
Breast implants at time of diagnosis; Note: patients who have had implants previously removed prior to diagnosis are eligible
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses
Have breast implants
MR-incompatible metal implants
Presence of metal implants
Patients with breast implants or expanders
Metallic implants
Metallic implants (contraindicated for MRI)
Implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization
Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
Patient received a permanent prostate brachytherapy implant within the last 3 months (for palladium [Pd]-103 implants) or 12 months (for iodine [I]-125 implants)
Metal implants in field of view
Metallic implants (contraindicated for MRI)
Metallic implants (contraindicated for MRI)
Electrical implants such as cardiac pacemakers or perfusion pumps
Patients with breast implants
Electrical implants such as cardiac pacemakers or perfusion pumps
Metallic implants
Metallic implants
Contraindication to MRI (metal implants)
Have electrically, magnetically, or mechanically activated implants that would preclude MRI
Breast implants allowed
Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which the Sponsor considers will interfere with the Calypso System's electromagnetic localization (note that the Sponsor will review a patient's implanted metal on a case by case basis).