MRI for Detecting Cancer in Women Who Are at High Risk of Developing Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00003736|
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : September 24, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: motexafin gadolinium Procedure: biopsy Procedure: breast imaging study Procedure: comparison of screening methods Procedure: magnetic resonance imaging Procedure: study of high risk factors||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Official Title:||Pilot Study: High Risk Breast Cancer Screening Pilot Study|
|Study Start Date :||June 1999|
|Actual Primary Completion Date :||June 2002|
|Actual Study Completion Date :||June 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003736
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80010|
|Porter Adventist Hospital|
|Denver, Colorado, United States, 80210|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102-5037|
|United States, District of Columbia|
|Lombardi Cancer Center|
|Washington, District of Columbia, United States, 20007|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|Simmons Cancer Center - Dallas|
|Dallas, Texas, United States, 75235-9154|
|United States, Virginia|
|Cancer Center at the University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|United States, Washington|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|University of Toronto|
|Toronto, Ontario, Canada, M5S 1A8|
|Study Chair:||Mitchell Schnall, PhD||Abramson Cancer Center of the University of Pennsylvania|