Prospective Radiologic Evaluation of Changes Following Fat Grafting

NCT ID: NCT01343030

Last Updated: 2019-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with implants

Patients with silicone implants and fat grafting.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women with silicone implants and fat grafting

Exclusion Criteria

* Procedures performed outside the University of Minnesota or Clinique Spontini Paris, France
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Institute for Basic and Applied Research in Surgery

UNKNOWN

Sponsor Role collaborator

Mentor Worldwide, LLC

INDUSTRY

Sponsor Role collaborator

Clinique SPONTINI

UNKNOWN

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce L Cunningham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Clinique SPONTINI

Paris, , France

Site Status

Countries

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United States France

Other Identifiers

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IBARS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1011M93112

Identifier Type: -

Identifier Source: org_study_id

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