Status:
ACTIVE_NOT_RECRUITING
Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
February 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 19 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04769960
Start Date
February 19 2021
End Date
February 19 2026
Last Update
May 18 2025
Active Locations (3)
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1
Memorial Sloan Kettering Bergen (Consent only )
Montvale, New Jersey, United States, 07645
2
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065