Spots Global Cancer Trial Database for Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
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Trial Identification
Brief Title: Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Official Title: MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer
Study ID: NCT00058058
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, 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
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States
Abramson Cancer Center at University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Toronto, Toronto, Ontario, Canada
Universitaetsklinikum Bonn, Bonn, , Germany
Contact Details
Name: Constance Lehman, MD, PhD
Affiliation: Seattle Cancer Care Alliance
Role: STUDY_CHAIR
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