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).