MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00003736
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for breast cancer. Diagnostic procedures such as MRI may improve the ability to detect breast cancer.
PURPOSE: Screening and diagnostic trial to study the effectiveness of MRI scans in women who are at high risk for developing breast cancer.
- Detailed Description
OBJECTIVES:
* Estimate the diagnostic yield and positive predictive value of breast magnetic resonance imaging (MRI) for the detection of cancer in women who are at greater than 25% lifetime risk for developing breast cancer.
* Compare the diagnostic yield and positive predictive value of MRI with conventional breast cancer screening (mammography and physical examination) for the detection of breast cancer in women with a greater than 25% lifetime risk of developing breast cancer.
OUTLINE: All patients receive a physical exam within 90 days of initial MRI scan. Patients undergo a two view screening mammogram within 3 months prior to study entry. Patients undergo an MRI with gadolinium contrast at entry. All lesions identified as suspicious on physical examination, mammography, or MRI undergo a core needle or excisional biopsy.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States