Cancer Center conducts a study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy

Memorial Sloan Kettering Cancer Center is recruiting patients for the clinical trial of Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy.

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.

The researchers plan that February 19, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in February 19, 2023.

Among primary outcome measures are the Safety of MRI scans for patients with breast tissue expanders. The first aim is to assess the safety of imaging patients with breast tissue expanders in the MRI. Among the 24 MRI scans, if investigators can successfully complete at least 20, 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.

The study will take place at the Memorial Sloan-Kettering Cancer Center, New York, United States.

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.

The population that can be enrolled into this study includes:

  • 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

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04769960

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