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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Adenocarcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Bergen (Consent only ), Montvale, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI Studies

Diagnostic 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 Outcomes

Behavioral

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.

Primary outcomes

Safety of MRI scans for patients with breast tissue expanders

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Feb 25, 2021
Registry last updated: May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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