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

This study is currently recruiting participants.
Verified March 2013 by Northwestern University
Sponsor:
Collaborator:
Robert H. Lurie Cancer Center
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT01259076
First received: December 10, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Healthy, no Evidence of Disease
 Procedure: magnetic resonance imaging
Procedure: digital mammography
Procedure: conventional surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Weight Loss on Breast Density Using Both Digital Mammography and Breast MRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in BMI and breast density [ Time Frame: At baseline and year 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: digital mammography
Undergo digital mammography at baseline and 1 year later.
Procedure: conventional surgery
Undergo gastric bypass surgery
Other Name: 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
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: digital mammography
Undergo digital mammography at baseline and 1 year later.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259076

Contacts
Contact: Research Coordinator 312-695-1301 cancertrials@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Nora Ma Hansen     312-472-4779     nhansen@nmh.org    
Contact: Research Coordinator     312-695-1301     cancertrials@northwestern.edu    
Principal Investigator: Nora Ma Hansen            
Sponsors and Collaborators
Northwestern University
Robert H. Lurie Cancer Center
Investigators
Principal Investigator: Nora Hansen Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01259076     History of Changes
Other Study ID Numbers: NU 10B01, STU00038177
Study First Received: December 10, 2010
Last Updated: March 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013