Prospective Radiologic Evaluation of Changes Following Fa... | NCT01343030

Studies
Prospective Radiologic Evaluation of Changes Following Fat Grafting

NCT01343030

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Nov 1, 2019Actual

Enrollment

35Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States
France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IBARS	Other Grant/Funding Number	G10-0068

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010Actual

Primary Completion Date

Dec 31, 2015Actual

Completion Date

Dec 31, 2015Actual

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Apr 26, 2011

First Posted Date

Apr 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2019

Last Update Posted Date

Nov 1, 2019Actual

Name	Class
The Institute for Basic and Applied Research in Surgery	UNKNOWN
Mentor Worldwide, LLC	INDUSTRY
Clinique SPONTINI	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Label	Type	Description	Intervention Names
Patients with implants		Patients with silicone implants and fat grafting.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiologist dictations of mammograms	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.	We will obtain mammograms and MRIs of participants at intervals of 6 months for up to 24 months post fat grafting.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with silicone implants and fat grafting

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruce L Cunningham, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States
Clinique SPONTINI

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided