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Prospective Radiologic Evaluation of Changes Following Fat Grafting

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
The Institute for Basic and Applied Research in Surgery
Mentor Worldwide, LLC
Clinique SPONTINI
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01343030
First received: March 22, 2011
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 35
Study Start Date: September 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with implants
Patients with silicone implants and fat grafting.

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Women with silicone implants and fat grafting

Exclusion Criteria:

  • Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343030

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
France
Clinique SPONTINI
Paris, France
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
The Institute for Basic and Applied Research in Surgery
Mentor Worldwide, LLC
Clinique SPONTINI
Investigators
Principal Investigator: Bruce L Cunningham, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01343030     History of Changes
Other Study ID Numbers: G10-0068, IBARS
Study First Received: March 22, 2011
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board
France: IRB Clinique Spontini

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013