Abbreviated MRI Protocol: Initial Experience With Dotarem® (Gadoterate Meglumine)

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

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 protocols have diagnostic accuracy comparable to that of the conventional full MRI protocol. There are also promising results of ultrafast DCE-MRI studies with shorter breast MRI protocols that provide not only morphologic but also valuable kinetic information about a lesion. The shorter imaging times achieved with the abbreviated and the ultrafast DCE-MRI protocols have the potential to increase efficiency and lower cost by decreasing time in the MRI suite, which in turn may make breast MRI accessible for population-based mass screening. The focus of the proposed research is the investigation of an abbreviated MRI protocol with ultrafast imaging using Dotarem® (Gadoterate Meglumine).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Collaborator: Guerbet
• Treatments: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Criteria

Inclusion Criteria:

• 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 Criteria:

• Women with a history of adverse reactions to contrast media.

• Women with GFR below 30 mL/min/1.73m².