Prospective Radiologic Evaluation of Changes Following Fat Grafting
- Conditions
- Breast Cancer
- Registration Number
- NCT01343030
- Lead Sponsor
- University of Minnesota
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
- Women with silicone implants and fat grafting
- Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Radiologist dictations of mammograms 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Clinique SPONTINI
🇫🇷Paris, France