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

Healthy, no Evidence of Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01259076
• Other study ID #: NU 10B01
• Secondary ID: STU00038177
• Status: Terminated
• Phase: N/A
• First received: December 10, 2010
• Last updated: April 9, 2015
• Start date: February 2011
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease

Intervention

Procedure:
• magnetic resonance imaging
Undergo MRI at baseline and 1 year later.
• digital mammography
Undergo digital mammography at baseline and 1 year later.
• conventional surgery
Undergo gastric bypass surgery

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Robert H. Lurie Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI and breast density		At baseline and year 1	No