Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- University of Minnesota
- Enrollment
- 35
- Locations
- 2
- Primary Endpoint
- Radiologist dictations of mammograms
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Breast implants are currently used for cosmetic breast augmentation and in breast reconstruction following mastectomy for breast cancer. Fat grafting is a technique where fat is injected around the periphery of a breast implant to camouflage the transition between implant and the body. The investigators propose to show mammography images of women who have had breast implants with fat grafting to informed and blinded radiologists and evaluate their readings of the images.
Hypothesis: with mammographic screening, radiologists will be able to distinguish between findings associated with fat grafting and those which are suspicious for breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women with silicone implants and fat grafting
Exclusion Criteria
- •Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France
Outcomes
Primary Outcomes
Radiologist dictations of mammograms
Time Frame: We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting.
We will compare the Bi-Rad level score readings, and recommended follow-up of the blinded and non-blinded radiologist's read of study participants mammograms.