Contrast-enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Comparison of 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
1 month
No
Nola M. Hylton, PhD
Principal Investigator
University of California, San Francisco
United States: Institutional Review Board
CDR0000616972
NCT00804128
October 2008
Name | Location |
---|---|
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |