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

Active, not recruiting

• Conditions: Breast Cancer; Breast Neoplasms; Breast Adenocarcinoma
• Interventions: Diagnostic Test: MRI Studies; Behavioral: Patient Reported Outcomes

• Registration Number: NCT04769960
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-19
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-25
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-02-19
• Study Completion: 2026-02-19

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with breast tissue expanders	MRI Studies	Participants with breast tissue expanders that require an MRI for clinical purposes are eligible for this study.
Participants with breast tissue expanders	Patient Reported Outcomes	Participants with breast tissue expanders that require an MRI for clinical purposes are eligible for this study.

Primary Outcome Measures

Name	Time	Method
Safety of MRI scans for patients with breast tissue expanders	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.

Trial Locations

Locations (3)

Memorial Sloan Kettering Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

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