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

Memorial Sloan Kettering Cancer Center3 sites in 1 country68 target enrollmentFebruary 19, 2021

ConditionsBreast Cancer Breast Neoplasms Breast Adenocarcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 68
Locations: 3
Primary Endpoint: Safety of MRI scans for patients with breast tissue expanders
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 19, 2021

End Date

February 19, 2026

Last Updated

11 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

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.