Prospective Radiologic Evaluation of Changes Following Fat Grafting

Breast Cancer Clinical Trial

Official title:

Prospective Radiologic Evaluation of Changes That Might Affect Breast Cancer Diagnosis Following Fat Grafting and Silicone Breast Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343030
• Other study ID #: 1011M93112
• Secondary ID: IBARS
• Status: Completed
• Start date: September 2010
• Est. completion date: December 31, 2015

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• Women with silicone implants and fat grafting

Exclusion Criteria:

• Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
France	Clinique SPONTINI	Paris
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
University of Minnesota	Clinique SPONTINI, Mentor Worldwide, LLC, The Institute for Basic and Applied Research in Surgery

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologist dictations of mammograms	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.	We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting.