Effect of Weight Loss on Breast Density Using Digital Mammography and MRI in Women Who Are At Increased Risk For Breast Cancer

Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI

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.

Study Overview

• Status: Terminated
• Conditions: Healthy, no Evidence of Disease
• Intervention / Treatment: Procedure: magnetic resonance imaging; Procedure: digital mammography; Procedure: conventional surgery

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Participants who are eligible for and have opted to undergo gastric bypass surgery	Procedure: magnetic resonance imaging; Undergo MRI at baseline and 1 year later.; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging; Procedure: digital mammography; Undergo digital mammography at baseline and 1 year later.; Procedure: conventional surgery; Undergo gastric bypass surgery; Other Names: surgery, conventional
Group 2; Participants who are eligible for but decided not to undergo gastric bypass surgery.	Procedure: magnetic resonance imaging; Undergo MRI at baseline and 1 year later.; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging; Procedure: digital mammography; Undergo digital mammography at baseline and 1 year later.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Robert H. Lurie Cancer Center
• Investigators: Principal Investigator: Nora Hansen, Northwestern University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: December 10, 2010
• First Submitted That Met QC Criteria: December 10, 2010
• First Posted (Estimate): December 13, 2010

Study Record Updates

• Last Update Posted (Estimate): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: NU 10B01; STU00038177 (Other Identifier: Northwestern University IRB)