This phase IV trial studies how well a new type of magnetic resonance imaging (MRI) exam called gadolinium contrast-enhanced abbreviated MRI (AMRI) works compared to a standard ultrasound exam to detect hepatocellular carcinoma (HCC) in patients with cirrhosis. Ultrasound is routinely used to monitor the livers of patients with cirrhosis who are at risk for HCC and to make decisions about their treatment. However, ultrasound has some limitations and is not the best choice for every patient. For these patients, computed tomography (CT) or MRI may be used. Gadolinium contrast is a liquid that is injected into the veins to make the organs more visible on MRI scans. This study will look at patients with cirrhosis to compare how well AMRI works compared to ultrasound to detect HCC.
Additional locations may be listed on ClinicalTrials.gov for NCT04288323.
Locations matching your search criteria
United States
California
San Diego
UC San Diego Medical Center - HillcrestStatus: Active
Contact: Kathryn Jane Fowler
PRIMARY OBJECTIVES:
I. Diagnostic performance of imaging for HCC screening.
Ia. Determinants of incorrectly scored exams.
II. Reader reliability of imaging for HCC screening.
IIa. Determinants of discordantly scored exams.
EXPLORATORY OBJECTIVE:
I. Patient-reported outcomes.
OUTLINE:
Within a 2 week window, patients complete 2 optional surveys over 15-30 minutes about their background, medical finances, and preferences concerning different kinds of imaging and undergo a standard US exam over 45-60 minutes. Patients also receive gadolinium intravenously (IV) and undergo AMRI exam over 30-45 minutes. Between 2-7 days after completion of US and AMRI exams, patients complete a third optional survey over 10 minutes about their experience.
After the completion of study, patients are followed up for up to 6 months.
Lead OrganizationUC San Diego Medical Center - Hillcrest
Principal InvestigatorKathryn Jane Fowler