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MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral breast cancer. PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected breast of women recently diagnosed with unilateral breast cancer.
OBJECTIVES: * Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the contralateral breast of women with a recent unilateral diagnosis of breast cancer and a negative contralateral mammogram and clinical breast exam. * Determine the sensitivity, specificity, positive predictive value for both call backs for additional imaging and biopsy recommendations, and receiver operating characteristic curves of MRI in evaluating these patients. * Determine the effect of the following patient-related factors: age (50 years old and over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast), and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the performance of MRI (cancer yield, sensitivity, specificity, and PPV). OUTLINE: This is a multicenter study. Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of the contralateral breast. Patients are followed at 12-18 and 24-30 months. PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Age
18 - 120 years
Sex
FEMALE
Healthy Volunteers
No
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Porter Adventist Hospital
Denver, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Boca Raton Community Hospital
Boca Raton, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Start Date
February 1, 2003
Primary Completion Date
August 8, 2006
Completion Date
August 1, 2008
Last Updated
July 16, 2019
1,007
ACTUAL participants
MRI
PROCEDURE
Lead Sponsor
American College of Radiology Imaging Network
Collaborators
NCT04704661
NCT05372640
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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