Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy

Study Overview
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Brief Summary
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The purpose of this study is to find out whether it is safe to perform MRI scans in people who have breast tissue expanders in place.

Official Title
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A Pilot Safety Study for Performing MRI in Patients Who Have Breast Tissue Expanders

Conditions
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Breast Cancer, Breast Neoplasms, Breast Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: MRI Studies
* Behavioral: Patient Reported Outcomes


Participation Criteria
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Eligibility Criteria
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Patients with breast tissue expanders that require an MRI for clinical purposes are eligible for this study. Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander. Breast tissue expanders marked as MRI unsafe will be allowed with exceptions as described in the Participant exclusion criteria. While all types of MRI will be included in this study, including breast MRI, we anticipate that most of the MRI examinations ordered will evaluate the brain or spine for detecting or following metastasis. Inclusion Criteria: Patient ≥ 18 years old on day of signing informed consent Has a breast tissue expander implanted > 28 days ago Patients must provide an implant card or surgical report indicated the exact make and model of their implanted tissue expander Exclusion Criteria: Patients with AeroForm Tissue Expanders (manufactured by AirXpanders) Anyone who would normally be excluded from undergoing an MRI examination as per the Memorial Hospital for Cancer and Allied Diseases screening policy in the MRI Safety Policy (https://one.mskcc.org/sites/pub/ehs/Policies/ECSE-2009.pdf), aside from having a breast tissue expander Patients who are reportedly pregnant, who have a positive urine or serum pregnancy test at the time of imaging, or for which pregnancy cannot be ruled out. Patients who are unable to tolerate, comply or complete the MRI exam due to claustrophobia, anxiety, known psychiatric or substance abuse disorder, age, frailty, or medical instability.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with breast tissue expanders<br>Participants with breast tissue expanders that require an MRI for clinical purposes are eligible for this study. | Diagnostic Test: MRI Studies<br>* MRI scans will be performed on a 1.5T MRI scanner. Department of Radiology MRI SafetyGuidelines will be followed except regarding breast tissue expanders. Conventional MRIstudies will be performed using the standard of care clinical sequences.<br>Behavioral: Patient Reported Outcomes<br>* Participants will fill out questionnaires before, immediately after, and approximately 3 months following the MRI examination +/- 1 month to evaluate for any pain or perceived changes with the breast tissue expander. The first questionnaire will obtain background participants information as well as establish a baseline pain level, the second questionnaire will evaluate any changes in pain after undergoing the MRI examination, and the last questionnaire will evaluate long term changes in pain. The patient reported outcome questionnaire will be optional at 3 months post-MRI +/-1 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of MRI scans for patients with breast tissue expanders | Our first aim is to assess the safety of imaging patients with breast tissue expanders in the MRI. Among the 50 MRI scans, if we can successfully complete at least 50, meaning that there are no issues of burning, heating, or pain in the region of the breast tissue expander that prevents the completion of the MRI, then we will declare the imaging safe and worthy of further investigation. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast tissue expander, breast cancer, mastectomy, 21-055, Memorial Sloan Kettering Cancer Center