Effect of Weight Loss on Breast Density Using Digital Mam... | NCT01259076

ID	Type	Description	Link
STU00038177	Other Identifier	Northwestern University IRB

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was closed early due to slow accrual.

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Dec 10, 2010

First Submission Date that Met QC Criteria

Dec 10, 2010

First Posted Date

Dec 13, 2010Estimated

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

Apr 9, 2015

Last Update Posted Date

Apr 10, 2015Estimated

Name	Class
Robert H. Lurie Cancer Center	OTHER

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

Diagnostic procedures, such as digital mammography and MRI, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.

Detailed Description

OBJECTIVES: I. To determine if weight loss in patients undergoing Roux en Y gastric bypass procedures has any effect on breast density as measured by mammography and breast MRI. OUTLINE: GROUP I: Participants undergo mammography and MRI at baseline and 1 year. Participants also undergo gastric bypass surgery. GROUP II: Participants undergo mammography and MRI at baseline and 1 year. After completion of study treatment, patients are followed up at 1 year.

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

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Participants who are eligible for and have opted to undergo gastric bypass surgery	Procedure: magnetic resonance imaging Procedure: digital mammography Procedure: conventional surgery
Group 2		Participants who are eligible for but decided not to undergo gastric bypass surgery.	Procedure: magnetic resonance imaging Procedure: digital mammography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
magnetic resonance imaging	Procedure	Undergo MRI at baseline and 1 year later.	Group 1 Group 2

Measure	Description	Time Frame
Change in BMI and breast density		At baseline and year 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women eligible for gastric bypass surgery
Pre-menopausal women
All women will have signed an informed consent form prior to participating in study procedures

Exclusion Criteria:

Women with a history of breast cancer
Women currently taking exogenous hormone replacement therapy
Women currently taking a SERM
Women currently taking an aromatase inhibitor
Pregnant or lactating women
Women who have been pregnant or lactating in the past 2 years
Women who have metallic or other surgical implants
All subjects will have a determination of their estimated glomerular filtration rate (eGFR) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered
Subjects should not have a known history of recent onset acute renal dysfunction
Subjects with a history of stable chronic renal dysfunction may participate in studies using GBCA based on their eGFR, as outlined below
Subjects should not have severe liver dysfunction, particularly when associated with kidney disease
Subjects should receive GBCAs in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Pre-menopausal women between the ages of 30 and 50 who are eligible and undergoing evaluation for gastric bypass surgery

Sampling Method

Non-Probability Sample

ID	Term
D009682	Magnetic Resonance Spectroscopy
D013514	Surgical Procedures, Operative
D003226	Congresses as Topic

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D009938	Organizations
D004472	Health Care Economics and Organizations