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Prospective Radiologic Evaluation of Changes Following Fat Grafting

NCT01343030 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2019-11-01

No results posted yet for this study

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

Sponsors & Collaborators

  • The Institute for Basic and Applied Research in Surgery

    collaborator UNKNOWN

  • Mentor Worldwide, LLC

    collaborator INDUSTRY

  • Clinique SPONTINI

    collaborator UNKNOWN

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Bruce L Cunningham, MD · University of Minnesota

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States
  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343030 on ClinicalTrials.gov