Abbreviated MRI (AMRI) Vs. Ultrasound for HCC Surveillance in Cirrhosis

Who is this study for? Adults with Hepatocellular Carcinoma and Cirrhosis
What treatments are being studied? Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study compares gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for Hepatocellular Carcinoma (HCC) screening and surveillance in subjects with liver cirrhosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.

• Adult subjects of any gender and any ethnic group with liver cirrhosis of any etiology,

• Subject is able and willing to complete required research procedures (screening/enrollment, clinical evaluation, safety procedures, lab collection if needed, research AMRI exam, research US exam) and the three optional surveys (if subject opts in for that) within specified time windows, and is willing to allow the study team to review clinical data including but not limited to other clinical radiology reports and images.

Locations
United States
California
University of California, San Diego
RECRUITING
La Jolla
Contact Information
Primary
Alexandra Schlein
a1schlein@health.ucsd.edu
(858) 246- 2199
Backup
Yesenia Covarrubias
ycovarrubias@health.ucsd.edu
(858) 246 - 2198
Time Frame
Start Date: 2018-04-27
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 150
Treatments
Experimental: Single arm
This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam
Related Therapeutic Areas
Sponsors
Collaborators: Icahn School of Medicine at Mount Sinai, Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov

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