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

NCT01259076 | Terminated DMC

• 2 other identifiers: NU 10B01STU00038177
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

• Change in BMI and breast density

  At baseline and year 1

Study Arms (2)

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

magnetic resonance imaging PROCEDURE

Undergo MRI at baseline and 1 year later.

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Group 1; Group 2

digital mammography PROCEDURE

Undergo digital mammography at baseline and 1 year later.

Group 1; Group 2

conventional surgery PROCEDURE

Undergo gastric bypass surgery

Also known as: surgery, conventional

Group 1

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Robert H. Lurie Cancer Center: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Surgical Procedures, Operative; Congresses as Topic

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Organizations; Health Care Economics and Organizations

Study Officials

• Nora Hansen

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: February 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

US (1)