Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
The Institute for Basic and Applied Research in Surgery
Mentor Worldwide, LLC
Clinique SPONTINI
University of Minnesota
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with silicone implants and fat grafting
Exclusion criteria
* Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France, United States
Outcome results
None listed