NCT00058058

Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer

MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,007 (actual)
• Sponsor: American College of Radiology Imaging Network · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Contralateral Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	MRI	Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.

Timeline

• Start date: 2003-02-01
• Primary completion: 2006-08-08
• Completion: 2008-08-01
• First posted: 2003-04-09
• Last updated: 2019-07-16
• Results posted: 2018-07-27

Locations

21 sites across 3 countries: United States, Canada, Germany