Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
A Pilot Safety Study for Performing MRI in Patients Who Have Breast Tissue Expanders
1 other identifier
observational
68
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2021
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2021
CompletedFirst Submitted
Initial submission to the registry
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2026
CompletedMay 18, 2025
May 1, 2025
5 years
February 22, 2021
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Participants with breast tissue expanders
Participants with breast tissue expanders that require an MRI for clinical purposes are eligible for this study.
Interventions
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.
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 Criteria
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alicia Meng, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
February 25, 2021
Study Start
February 19, 2021
Primary Completion
February 19, 2026
Study Completion
February 19, 2026
Last Updated
May 18, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.