Prospective Radiologic Evaluation of Changes Following Fat Grafting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants|
- 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. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients with implants
Patients with silicone implants and fat grafting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343030
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Bruce L Cunningham, MD||University of Minnesota - Clinical and Translational Science Institute|