Breast Adenocarcinoma, Breast Cancer, Breast Neoplasms
Conditions
Keywords
breast tissue expander, breast cancer, mastectomy, 21-055, Memorial Sloan Kettering Cancer Center
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.
Interventions
DIAGNOSTIC_TESTMRI Studies
MRI scans will be performed on a 1.5T MRI scanner. Department of Radiology MRI SafetyGuidelines will be followed except regarding breast tissue expanders. Conventional MRIstudies will be performed using the standard of care clinical sequences.
BEHAVIORALPatient Reported Outcomes
Participants will fill out questionnaires before, immediately after, and approximately 3 months following the MRI examination +/- 1 month to evaluate for any pain or perceived changes with the breast tissue expander. The first questionnaire will obtain background participants information as well as establish a baseline pain level, the second questionnaire will evaluate any changes in pain after undergoing the MRI examination, and the last questionnaire will evaluate long term changes in pain. The patient reported outcome questionnaire will be optional at 3 months post-MRI +/-1 month.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of MRI scans for patients with breast tissue expanders | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlicia Meng, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed