Prospective Radiologic Evaluation of Changes Following Fat Grafting

NCT01343030 | Completed DMC

• 2 other identifiers: 1011M93112IBARS
• Study Type: observational
• Target: 35
• Locations: 2 countries
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patients with implants

Patients with silicone implants and fat grafting.

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will select patients from Clinique Spontini Paris France and from patients at the University of Minnesota USA who have undergone placement of silicone breast implants with fat grafting.

You may qualify if:

• Women with silicone implants and fat grafting

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead
• The Institute for Basic and Applied Research in Surgery: collaborator
• Mentor Worldwide, LLC: collaborator
• Clinique SPONTINI: collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Clinique SPONTINI

Paris, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bruce L Cunningham, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: April 27, 2011
• Study Start: September 1, 2010
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1); FR (1)