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Imaging

MRI vs. Ultrasound Screening for Liver Cancer (PREMIUM Trial)

N/A
Recruiting
Research Sponsored by VA Office of Research and Development
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 8 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different screening methods for early detection of liver cancer in patients with cirrhosis of the liver.

Who is the study for?
This trial is for adults aged 18-75 with liver cirrhosis, diagnosed through biopsy or other specific medical criteria. Participants must be at high risk of developing liver cancer but cannot have had a prior diagnosis of HCC, organ transplants, severe comorbid conditions, or certain metal implants that interfere with MRI scans.
What is being tested?
The PREMIUM study compares two screening methods for early detection of liver cancer in high-risk patients: abbreviated MRI plus serum AFP test versus standard abdominal ultrasound plus serum AFP test. The aim is to find out if the former can detect cancer earlier and reduce mortality.
What are the potential side effects?
Potential side effects mainly relate to undergoing an MRI scan and may include discomfort from lying still during the procedure, loud noises from the machine, reactions to contrast agents used (if any), and anxiety or claustrophobia within the confined space of the scanner.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hepatocellular Carcinoma Mortality
Secondary study objectives
Overall Survival
Receipt of potentially curative treatments for Hepatocellular Carcinoma
Stage of Hepatocellular Carcinoma at diagnosis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abbreviated Magnetic Resonance Imaging with serum AFPExperimental Treatment1 Intervention
Abdominal aMRI+ serum AFP every 6 months from the time of recruitment until the end of year 8
Group II: Abdominal Ultrasound Screening with serum AFPActive Control1 Intervention
abdominal ultrasound (US)+serum alpha fetoprotein (AFP) every 6 months from the time of recruitment until the end of year 8

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,761,109 Total Patients Enrolled
George N. Ioannou, MD MSStudy ChairVA Puget Sound Health Care System Seattle Division, Seattle, WA
2 Previous Clinical Trials
400,731 Total Patients Enrolled

Media Library

Abbreviated Magnetic Resonance Imaging with serum AFP (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05486572 — N/A
Liver Cancer Research Study Groups: Abbreviated Magnetic Resonance Imaging with serum AFP, Abdominal Ultrasound Screening with serum AFP
Liver Cancer Clinical Trial 2023: Abbreviated Magnetic Resonance Imaging with serum AFP Highlights & Side Effects. Trial Name: NCT05486572 — N/A
Abbreviated Magnetic Resonance Imaging with serum AFP (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05486572 — N/A
~3133 spots leftby Sep 2030
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