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
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
Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps
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
Implanted pacemaker, defibrillator, deep brain stimulator, or other implanted electronic devices in the brain or other documented clinically significant arrhythmias
Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body
Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device
Implantable electronic medical devices in the brain
Placement of a pacemaker for control of rhythm
Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso
Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc…)
Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
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
Have implanted cardiac pacemakers or defibrillators
Have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
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
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
Subjects unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator [ICD] device) or unwilling to have a head contrast enhanced MRI.
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)).
No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.
Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
Subjects who have a contraindication for 3T MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
Patients with a pacemaker or defibrillator
Any contraindication to MRI including but not limited to the presence of a pacemaker/defibrillator or other implanted ferromagnetic device or an inability to lie prone
Symptomatic bradycardia in the absence of a pacemaker.
Subjects who have a contraindication for 3 tesla (3T) MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
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.
Electrical implants such as cardiac pacemakers or perfusion pumps
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 with a permanent pacemaker
Patients with a pacemaker
Placement of a pacemaker for control of rhythm.
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)
Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices); an MRI safety questionnaire is required prior to magnetic resonance (MR) imaging
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)
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord.
Metal in the body (except dental fillings) e.g., pacemaker, infusion pump, metal aneurysm clip, metal prosthesis, joint, rod or plate.
Subjects unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter-defibrillator [ICD] device) or unwilling to have a head contrast enhanced MRI
Patients with a contraindication to MRI such as implanted metal devices or foreign bodies or severe claustrophobia
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
Presence of cardiac pacemaker or implantable cardioverter-defibrillator
Contraindications to MRI, including claustrophobia, metallic implants, and pacemakers
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
Contraindication for contrast-enhanced MRI as defined by the standard operating procedures of the Department of Radiology at University of Texas (UT) Southwestern; briefly, these include medically unstable; cardiac pacemaker; intracranial clips, metal implants; metal in the eyes; pregnant or nursing; claustrophobia; and impairment of the renal function with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2; patients with one or more of these contraindications but eligible to undergo contrast-enhanced CT can participate in this study and will not receive an MRI
Prosthetic implants in the pelvic region that contain metal materials (e.g., an artificial hip)
MRI MONITORING SUB-STUDY: Implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants
Patients who are pacemaker or defibrillator-dependent
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds) or severe anxiety/claustrophobia related to MR imaging despite medications to relieve anxiety/claustrophobia (first 10 patients only; however, an investigator can still choose to enroll patients onto the trial who have these contra- indications to MRI; these patients will not receive the two research MRIs at the Wright Center)
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
Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices); an MRI safety questionnaire is required prior to magnetic resonance (MR) imaging
Patients with pacemakers, ferro-magnetic aneurysm clips, metal infusion pumps, metal or shrapnel fragments or certain types of stents
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
Presence of pacemaker or intracranial aneurysm clip
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.
Patients with pacemaker, defibrillator, or documented significant arrhythmia, are not allowed
Any contraindication to MRI (i.e. patients with pacemakers or other metal implanted medical devices)
Intracranial aneurysm clips (except Sugita) or other metallic objects
Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-MR conditional heart valves
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 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.
Contraindication to magnetic resonance imaging (MRI), including presence of a pacemaker or aneurysm clip, severe claustrophobia, a known reaction to gadolinium contrast, or body weight exceeding 300 pounds (lbs)
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
Presence of a pacemaker
The subject has an implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
Implantable pacemaker or implantable cardioverter defibrillator
Patients with pacemaker or an implantable cardioverter defibrillator (ICD) devices
Placement of a pacemaker for control of rhythm
Patients unable to undergo or tolerate MRI scans (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, history of allergic reaction/hypersensitivity to gadolinium)
Known contraindication to MRI, such as cardiac pacemaker, shrapnel or ocular foreign body.
Has implanted medical devices that pose high risks for colonization and cannot be easily removed
Subject is pacemaker dependent
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.
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
Known contraindication to MRI, such as cardiac pacemaker, shrapnel, or ocular foreign body
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.
Unable to have pelvic MRI scanning (severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc., likely to contribute significant artifact to images).
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
Placement of a pacemaker for control of rhythm;
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
Metallic implants, claustrophobia not amenable to medication, or known contraindications to undergoing magnetic resonance (MR) scanning
Patients unable to obtain magnetic resonance imaging (MRI) for any reason (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity)
Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
Absolute contraindication for MRI imaging such as intracorporeal metal or pacemaker
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.
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)
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.
A pacemaker or implantable cardiac defibrillator
Subject with intra-cardiac defibrillators or pacemaker
Known contraindication to MRI with gadolinium contrast, such as cardiac pacemaker, shrapnel, or ocular foreign body
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 pacemakers or any metallic objects as exclusion for MRI
Cardiac pacemaker or other metallic implants which would prevent patient from safely undergoing MRI scan
Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies, severe claustrophobia AND patients unable to receive gadolinium contrast agents
Patients with a permanent pacemaker
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
Has a heart pacemaker or other electronic device implants
Implantable pacemaker or implantable cardioverter defibrillator
Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
Patients meeting the following exclusion criteria will be excluded from the magnetic resonance imaging (MRI) portion only: \r\n* Metallic implant, e.g. pacemaker, defibrillator \r\n* Unmanageable claustrophobia \r\n* High risk for nephrogenic systemic fibrosis
Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
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:
Contraindication to magnetic resonance (MR) imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration
Implantable pacemaker or implantable cardioverter defibrillator
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
Pacemaker/defibrillator
Patients with metal implants less than 5 cm from the treatment
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.
Implantable pacemaker or automatic implantable cardioverter defibrillator
Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagus nerve stimulator, and other implanted electronic devices in the brain or the spinal cord
Obligate use of a cardiac pacemaker or implantable cardioverter defibrillator
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.
Metallic hip implant, metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of multiparametric (MP)-MRI
Patients who are pacemaker or defibrillator-dependent
Patient is pacemaker dependent
Obligate use of a cardiac pacemaker or implantable cardioverter defibrillator
No contraindications for magnetic resonance imaging (MRI) (e.g., unsafe MRI implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia)
Have any active implanted electronic device (e.g., pacemaker),
Obligate need for a cardiac pacemaker;
Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
Patients with a pacemaker
implanted devices that cannot be easily removed
Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain.
Implanted metal or metal devices that make a MRI scan prohibitive, history of claustrophobia or other condition that would make a MRI scan prohibitive
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)
Any of the following: diagnosis of schizophrenia or bipolar disorder made by a physician, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, or the presence of other known current untreated causes of fatigue such as anemia (defined as hemoglobin [Hgb] < 10 g/dL within 3 months of study enrollment) or untreated hypothyroidism
The presence of more than mild valvular stenosis or regurgitation, prosthetic valves or pacemaker on their baseline echocardiogram
Cardiac pacemaker or other implanted electronic devices
Metal implants for the treatment extremity
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)
Patients with known claustrophobia, presence of pacemaker and/or ferromagnetic material in their body that would prohibit MRI imaging (ex. tissue expanders)
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
Pacemaker
Contraindication to magnetic resonance (MR) imaging such as implanted metal devices or foreign bodies
History of a medical condition or procedure that is contraindicated for fMRI scanning (i.e. cardiac pacemaker, sternal wires, or metal implants); and
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
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)
For the subset of participants undergoing neuroimaging:\r\n* Medical history or devices which make an MRI unsafe or uncomfortable (e.g., magnetic rods or pins, metal plates or screws, pacemaker)
No implanted medical devices or implanted metal in the head
Presence of permanent pacemaker or implantable medical device\r\n* Artificial joint prostheses and venous filters are allowed
Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;
For local participants undergoing bioelectrical impedance measurements: pregnancy, metal implants, and defibrillator implants
Contraindication to magnetic resonance (MR) imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration
Pacemaker or other electronic implanted device
Patients with cardiac pacemakers or other implanted electronic devices
Patient has metal implants near the surgical site that preclude treatment with the microwave system
Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
Patients with implantable pacemakers and other electronic implants, in accordance with Instructions for Use (IFU).
Presence of a metal biliary stent
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
Women with implants
Participants with non- magnetic resonance (MR) compatible objects or implants that would make MRI a contraindication
Participants who have a pacemaker, pacer wires, implantable defibrillator, or implanted monitoring device
Participants with intracranial clips, metal implants or external clips within 10 mm of the head
Participants who have had a metal injury to the eye
Patients will be excluded from functional magnetic resonance imaging (fMRI) testing if they are left-handed, claustrophobic, have a pacemaker, or have metal implants; patients not fMRI testing may still enroll in clinical trial, including the event related potentials (ERP) testing, if all other eligibility criteria are met
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
Contraindication to a cardiac magnetic resonance (CMR) (metallic object, severe claustrophobia, pacemaker, vascular clip)
Metal implants on same limb as intended administration site
Pacemaker or other implanted device
Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
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.
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)
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses.
Metal medical implantable device or other MRI incompatible materials
Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses
Have a pacemaker
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
Patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (Calypso) that might distort local magnetic field and compromise quality of MP-MRI
Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander)
Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
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
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
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 who have a contraindication for 3 tesla (T) MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
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
An implanted pacemaker or cardiac defibrillator
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])
MR-incompatible metal implants
Presence of metal implants
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)
Patients who have presence of a known contradiction to MRI\r\n* Pacemaker\r\n* Aneurysm clips\r\n* Patients with implants that are contradicted for magnetic resonance (MR) imaging will be excluded\r\n* Pregnant\r\n* Age and mental status wherein he/she is unable to cooperate for MRI study
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
Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants)
No implanted metallic objects
Contraindication to MRI (i.e. pacemakers, aneurysm clips, or shrapnel fragments)
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium containing contrast material
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
The presence of an implanted pacemaker or implanted defibrillator device
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
Implanted medical device not described above that is not MRI-compatible
Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac magnetic resonance imaging (MRI)
Pacemaker of other implantable device in the chest wall
Patients unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips
Metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
Patients unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips
Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
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
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
Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
Presence of an implanted device that is incompatible with CT scanning
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
Active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps
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
Participants/volunteers with a pacemaker, aneurysm clip, or any other condition that would warrant avoidance of a strong magnetic field
Standard MRI exclusion criteria will also be applied, including pacemakers and metal clips located in the patient
Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
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 surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
Patients with left bundle branch block (LBBB) and/or artificial pacemaker
Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
The presence of an implanted pacemaker or implanted defibrillator device
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
Implanted medical device not described above that is not MRI-compatible
Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)
Participants who have a contraindication for MRI (e.g. metal in their bodies, a cardiac pacemaker, or other incompatible device), or are severely agitated or claustrophobic
Patients with pacemakers or other implanted magnetic devices that may malfunction or move in the strong magnetic field
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)
Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander)
Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
Subjects that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims
The patient should not participate in this study is any of the following applies to the patient: the patients has a pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, implanted electronic infusion pumps or any other condition that would interfere with the MRI, the patient has a stent somewhere in the body, the patient has a history of allergic reaction to any metals, contrast agents, x-ray dyes, the patient has claustrophobia
Patients who have cardiac pacemaker or other electronic or metal implant
Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander)
Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander)
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, need monitored anesthesia for scanning, or have an allergy to Gd contrast material
Pacemaker
Aneurysmal clips
Metal implants in field of view
Contraindications for MRI (e.g. cardiac pacemaker)
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
The presence of an implanted pacemaker or implanted defibrillator device
Implanted medical device not described above that is not MRI-compatible
Any contraindication to MR imaging (e.g., metal implant, aneurysm clip, pacemaker).
pacemaker,
surgical clips or other metallic implants;
Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
Subjects with a contraindication to an MRI including those with a pacemaker, ferromagnetic aneurysm clip, or cochlear implants
Electrical implants such as cardiac pacemakers or perfusion pumps
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
Electrical implants such as cardiac pacemakers or perfusion pumps
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
MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
Participants who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to GBCA
Participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo MRI examination
Metallic implants
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)
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
Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI
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
Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data
Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes
Subjects with a counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator)
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
Any implantable medical device that is not MRI compatible (e.g. pacemakers, defibrillators, pain pumps or insulin pumps)
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
Not suitable to undergo MRI with an extracellular gadolinium-based contrast agent that does not have dominant hepatobiliary excretion because of:\r\n* Claustrophobia, unless patient agrees to sedation measures per institutional standard practice during MR imaging\r\n* Presence of metallic objects or implanted medical devices in body per institutional safety standards\r\n* Sickle cell disease\r\n* Weight greater than that allowable by the MR table
Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
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
Metallic implants
Contra-indication to MRI (e.g. pacemaker, severe claustrophobia, suspected presence of MR-unsafe surgical implants or shrapnel)
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
Presence of a pacemaker or 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
Patients who have cerebral aneurysm clips
Patients who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
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 cerebral aneurysm clips
Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
Patient with a contraindication to MRI (e.g., pacemaker, aneurysm clip, severe claustrophobia, infusion pumps, cochlear implants metallic or others according to the imaging site standard practice)
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
Subject has pacemaker or other implantable device in the chest wall.
Presence of pacemaker/implantable cardioverter-defibrillator (ICD) or perfusion pumps
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
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
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)
Have a cardiac pacemaker or defibrillator device
Patients with metal implant or a cardiac pacemaker
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
Presence of a pacemaker or defibrillator
Has a pacemaker or other internal medical device, or reports being pregnant (PCS study)
Use of a ventricular-paced pacemaker
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).
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