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Prospective Radiologic Evaluation of Changes Following Fat Grafting

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ClinicalTrials.gov Identifier: NCT01343030
Recruitment Status : Unknown
Verified June 2014 by University of Minnesota - Clinical and Translational Science Institute.
Recruitment status was:  Enrolling by invitation
First Posted : April 27, 2011
Last Update Posted : June 11, 2014
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

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.


Condition or disease
Breast Cancer

Study Type : Observational
Estimated Enrollment : 35 participants
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
Study Start Date : September 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Patients with implants
Patients with silicone implants and fat grafting.



Primary Outcome Measures :
  1. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01343030     History of Changes
Other Study ID Numbers: G10-0068
IBARS ( Other Grant/Funding Number: G10-0068 )
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

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