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

Last updated: May 14, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Adenocarcinoma

Breast Cancer

Treatment

Patient Reported Outcomes

MRI Studies

Clinical Study ID

NCT04769960
21-055
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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 makeand model of their implanted tissue expander

Exclusion

Exclusion Criteria:

  • Patients with AeroForm Tissue Expanders (manufactured by AirXpanders)

  • Anyone who would normally be excluded from undergoing an MRI examination as per theMemorial Hospital for Cancer and Allied Diseases screening policy in the MRI SafetyPolicy (https://one.mskcc.org/sites/pub/ehs/Policies/ECSE-2009.pdf), aside fromhaving a breast tissue expander

  • Patients who are reportedly pregnant, who have a positive urine or serum pregnancytest 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 toclaustrophobia, anxiety, known psychiatric or substance abuse disorder, age,frailty, or medical instability.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Patient Reported Outcomes
Phase:
Study Start date:
February 19, 2021
Estimated Completion Date:
February 19, 2026

Connect with a study center

  • Memorial Sloan Kettering Bergen (Consent only )

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Memorial Sloan Kettering Commack (Consent Only)

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

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