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

N/AActive Not RecruitingNCT04769960

Memorial Sloan Kettering Cancer Center68 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Breast Neoplasms Breast Adenocarcinoma

Interventions

MRI StudiesDIAGNOSTIC_TEST

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.

Patient Reported OutcomesBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Memorial Sloan Kettering Bergen (Consent only )

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Consent Only)

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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