Status:
COMPLETED
Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Guerbet
Conditions:
Breast Neoplasms
Breast Diseases
Eligibility:
FEMALE
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
Standard breast MRI studies often have lengthy protocols that make them inherently expensive and time-consuming. Several studies of the use of abbreviated MRI protocols have shown that the shorter pro...
Detailed Description
Breast cancer is second to lung cancer as the leading cause of death among women in the United States. Over 40,000 women were estimated to die of breast cancer in 2016. Early detection is key to impro...
Eligibility Criteria
Inclusion
- Women between the ages of 18-80.
- Women with diagnostic imaging findings highly suspicious for breast cancer (BI-RADS category 4 or 5) or known breast cancer (BI-RADS category 6). Per BI-RADS lexicon, category 4 lesions carry a malignancy risk of 2-95% and category 5 lesions carry a malignancy risk of \>95%.
Exclusion
- Women with a history of adverse reactions to contrast media.
- Women with GFR below 30 mL/min/1.73m².
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04341129
Start Date
July 13 2020
End Date
June 30 2023
Last Update
December 5 2023
Active Locations (1)
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1
University of Chicago Medicine
Chicago, Illinois, United States, 60637