Prospective Radiologic Evaluation of Changes Following Fat Grafting

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.

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Key information

Conditions

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

Age range

18 year–84 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinique SPONTINI, Paris, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with silicone implants and fat grafting

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

Clinique SPONTINI
Mentor Worldwide, LLC
The Institute for Basic and Applied Research in Surgery

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Apr 27, 2011
Registry last updated: Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed