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ACTIVE NOT RECRUITING
NCT04769960

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

68

Start Date

2021-02-19

Completion Date

2026-02-19

Last Updated

2025-05-18

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

MRI Studies

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.

BEHAVIORAL

Patient Reported Outcomes

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.

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