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Breast MRI Protocol
RATIONALE: New imaging procedures, such as MRI, may improve the ability to detect breast tumors. PURPOSE: Diagnostic study to determine the value of MRI in detecting breast tumors in women who have had suspicious mammographic or clinical examinations.
OBJECTIVES: I. Evaluate the performance of breast magnetic resonance imaging (MRI) in conjunction with mammography for the detection and characterization of lesions in women with suspicious mammographic or clinical examinations. II. Assess the incremental value of breast MRI to determine the local extent of cancer in these patients. III. Assess the value of breast MRI to determine the prevalence and characteristics of incidental enhancing lesions in the remainder of the breast. OUTLINE: This is a multicenter study. Patients undergo a high resolution 3D post contrast magnetic resonance imaging (MRI) scan. Patients with enhancing abnormalities undergo a dynamic scan no less than 18 hours later. Some patients may require a third scan if a core biopsy is to be performed. Patients who are ultimately found to have cancer are assessed for extent of cancer including measurement of the index lesion and identification of other present foci of cancer in relation to the index lesion. Further histological diagnosis of index lesions is determined by MRI-guided needle localization excisional biopsy. Patients with benign needle biopsy are followed for 2 years. Patients with benign primary lesions receive a follow up MRI scan 1 year after the initial scan. Patients with benign primary lesions and incidental enhancing lesions (IEL) are followed at 2 years. Patients with negative needle biopsies not yielding a specific diagnosis and who do not undergo subsequent excisional biopsy are followed yearly for 2 years. PROJECTED ACCRUAL: A total of 1500 patients will be accrued for this study over 4.25 years.
Age
18 - 79 years
Sex
FEMALE
Healthy Volunteers
No
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Start Date
May 1, 1998
Primary Completion Date
June 30, 2000
Completion Date
June 30, 2000
Last Updated
September 25, 2019
1,500
ESTIMATED participants
biopsy
PROCEDURE
magnetic resonance imaging
DIAGNOSTIC_TEST
mammography
DIAGNOSTIC_TEST
Lead Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
NCT05245812
NCT05673200
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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