MRI to Detect Breast Tumors in Women
- Conditions
- Breast Cancer
- Registration Number
- NCT00003302
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1500
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 (15)
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Universitaetskliniken Bonn
🇩🇪Bonn, Germany
Martin Luther Universitaet
🇩🇪Halle Saale, Germany
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, 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
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada