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


N/A
18 Years
84 Years
Open (Enrolling by invite only)
Female
Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Women with silicone implants and fat grafting

Exclusion Criteria:

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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Radiologist dictations of mammograms

Outcome Description:

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.

Outcome Time Frame:

We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting.

Safety Issue:

Yes

Principal Investigator

Bruce L Cunningham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute

Authority:

United States: Institutional Review Board

Study ID:

G10-0068

NCT ID:

NCT01343030

Start Date:

September 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location
University of Minnesota Minneapolis, Minnesota  55455