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Contrast-Enhanced MRI in Women With Ductal Breast Carcinoma in Situ and in Healthy Volunteers - NCT00804128-94115(Clinical Trial 257769)



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City:  San Francisco
State:  
CA
Zip Code: 94115
Conditions: Breast Cancer
Purpose: RATIONALE: Diagnostic procedures, such as contrast-enhanced MRI, may help find and diagnose ductal carcinoma in situ. PURPOSE: This randomized clinical trial is studying contrast-enhanced MRI in women with ductal breast carcinoma in situ and in healthy volunteers.
Study summary: OBJECTIVES: - To compare ductal carcinoma in situ (DCIS)-optimized MRI with standard clinical MRI, in terms of conspicuity of DCIS lesion, agreement of disease extent with biopsy, and overall image quality (i.e., artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio), in women with DCIS of the breast. - To compare two DCIS-optimized MRIs for variability in enhancement levels for DCIS. - To examine the effect of the menstrual cycle on the variability of background enhancement levels in healthy volunteers. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms. - Arm I: Patients undergo standard clinical contrast-enhanced MRI over approximately 30-45 minutes. No more than 3 days later, patients undergo ductal carcinoma in situ (DCIS)-optimized contrast-enhanced MRI. - Arm II: Patients undergo DCIS-optimized contrast-enhanced MRI over approximately 30-45 minutes. No more than 3 days later, patients undergo a second DCIS-optimized contrast-enhanced MRI. Healthy volunteers undergo DCIS-optimized contrast-enhanced MRI as in arm II.
Criteria: DISEASE CHARACTERISTICS: - Meets 1 of the following criteria: - Patient at the University of California, San Francisco Breast Care Center meeting the following criteria: - Biopsy proven ductal carcinoma in situ (DCIS) of the breast - Has undergone mammography within the past 60 days - Healthy volunteer - No prior breast disease PATIENT CHARACTERISTICS: - Not pregnant or nursing (or stopped nursing within the past 3 months) - Negative pregnancy test - No contraindication to MRI (e.g., implanted pacemaker, implanted ferromagnetic device, ferromagnetic aneurysm clip, severe claustrophobia, ocular metal fragments, or shrapnel injury) PRIOR CONCURRENT THERAPY: - More than 2 years since prior surgery to the ipsilateral breast (patient) - No prior radiotherapy to the ipsilateral breast (patient) - No prior cytotoxic regimens (patient)
Study is available at: UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA 94115
United States

Primary Contact:
Clinical Trials Office - UCSF Helen Diller Family Comprehensi
Phone: 877-827-3222
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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