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Contrast Agent

AMRI vs. Ultrasound for Liver Cancer Surveillance

Phase 4
Recruiting
Led By Claude B Sirlin, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares the use of gadolinium contrast-enhanced Abbreviated MRI (AMRI) to standard ultrasound for the screening and surveillance of subjects with liver cirrhosis who are at risk for developing hepatocellular carcinoma (HCC).

Who is the study for?
This trial is for adults of any gender and ethnicity with liver cirrhosis who can sign consent, complete research procedures, and allow access to their clinical data. It's not for those under 18, pregnant or nursing women, patients with a history of liver cancer or known allergies to gadolinium agents, or anyone contraindicated for MRI.
What is being tested?
The study is testing if an Abbreviated MRI (AMRI) using Gadolinium contrast is better than standard ultrasound in screening for Hepatocellular Carcinoma (HCC) in people with liver cirrhosis. Participants will undergo both AMRI and ultrasound exams.
What are the potential side effects?
Potential side effects may include allergic reactions to the gadolinium contrast agent used during the AMRI procedure. These could range from mild skin rashes to more severe reactions depending on individual sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of full AMRI, simulated unenhanced AMRI, and US for HCC detection
Reader reliability of screening modalities

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment1 Intervention
This is a single arm study in which all participants have one ultrasound and one abbreviated MR exam

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,897 Total Patients Enrolled
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaIndustry Sponsor
25 Previous Clinical Trials
122,005 Total Patients Enrolled
1 Trials studying Liver Cancer
5 Patients Enrolled for Liver Cancer
Icahn School of Medicine at Mount SinaiOTHER
904 Previous Clinical Trials
541,655 Total Patients Enrolled
2 Trials studying Liver Cancer
1,400 Patients Enrolled for Liver Cancer

Media Library

Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Contrast Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04288323 — Phase 4
Liver Cancer Research Study Groups: Single arm
Liver Cancer Clinical Trial 2023: Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid Highlights & Side Effects. Trial Name: NCT04288323 — Phase 4
Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Contrast Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04288323 — Phase 4
~20 spots leftby Nov 2025
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