Trials / Active Not Recruiting
Active Not RecruitingNCT04769960
Study of the Safety of MRI Scans in People Who Have Breast Tissue Expanders After Mastectomy
A Pilot Safety Study for Performing MRI in Patients Who Have Breast Tissue Expanders
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | MRI 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. |
| BEHAVIORAL | Patient 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. |
Timeline
- Start date
- 2021-02-19
- Primary completion
- 2026-02-19
- Completion
- 2026-02-19
- First posted
- 2021-02-25
- Last updated
- 2025-05-18
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04769960. Inclusion in this directory is not an endorsement.