Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT04769960

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 3 Locations for this study

See Locations Near You

Memorial Sloan Kettering Bergen (Consent only )
Montvale New Jersey, 07645, United States More Info
Alicia Meng, MD
Contact
212-639-3994
Memorial Sloan Kettering Commack (Consent Only)
Commack New York, 11725, United States More Info
Alicia Meng, MD
Contact
212-639-3994
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States More Info
Alicia Meng, MD
Contact
212-639-3994

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT04769960

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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