Diagnostic Study of Magnetic Resonance Imaging in Evaluating the Contralateral Breast of Women With a Recent Unilateral Diagnosis of Breast Cancer
Last Modified: 8/2/2007  First Published: 3/24/2003
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
---|
No phase specified | Diagnostic | Completed | 18 and over | ACRIN-6667 NCT00058058 |
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).
Entry Criteria Disease Characteristics:
- Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast
- Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days
- Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days
- Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry
- Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry
- No remote history of breast cancer
- No new breast symptoms within the past 60 days for which further evaluation is recommended
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy - At least 6 months since prior anticancer chemotherapy
Endocrine therapy - No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed)
Radiotherapy Surgery Patient Characteristics:
Age Sex Menopausal status Performance status Life expectancy Hematopoietic Hepatic Renal Cardiovascular - No pacemaker
- No magnetic aneurysm clips
Other - Not pregnant
- No implanted magnetic device
- No severe claustrophobia
- No other contraindications to MRI
- No psychiatric, psychological, or other condition that would preclude informed consent
Expected Enrollment A total of 1,000 patients will be accrued for this study. 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. Published ResultsLehman CD, Gatsonis C, Kuhl CK, et al.: MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med 356 (13): 1295-303, 2007.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations American College of Radiology Imaging Network | | | Constance Lehman, MD, PhD, Protocol chair | | | |
Registry Information | | Official Title | | MRI Evaluation Of The Contralateral Breast In Women With Recent Diagnosis Of Breast Cancer | | Trial Start Date | | 2001-02-31 | | Registered in ClinicalTrials.gov | | NCT00058058 1 | | Date Submitted to PDQ | | 2003-02-12 | | Information Last Verified | | 2004-04-30 | | NCI Grant/Contract Number | | CA080098 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
1 | http://clinicaltrials.gov/ct/show/NCT00058058 |
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