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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

PREMIUM Trial 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.Check my eligibility

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.See study design

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.

PREMIUM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hepatocellular Carcinoma Mortality

Secondary outcome measures

Overall Survival

Receipt of potentially curative treatments for Hepatocellular Carcinoma

Stage of Hepatocellular Carcinoma at diagnosis

PREMIUM 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,301,729 Total Patients Enrolled

3 Trials studying Hepatocellular Carcinoma

8,113 Patients Enrolled for Hepatocellular Carcinoma

George N. Ioannou, MD MSStudy ChairVA Puget Sound Health Care System Seattle Division, Seattle, WA

1 Previous Clinical Trials

400,000 Total Patients Enrolled

Media Library

Abbreviated Magnetic Resonance Imaging with serum AFP (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT05486572 — N/A

Hepatocellular Carcinoma Research Study Groups: Abdominal Ultrasound Screening with serum AFP, Abbreviated Magnetic Resonance Imaging with serum AFP

Hepatocellular Carcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently accept enrollees?

"This trial, whose initial posting date was December 1st 2022 and most recent update was August 1st 2022, is no longer actively seeking participants. However, there are 877 other clinical trials currently recruiting volunteers from the public."

Answered by AI

Which individuals are eligible to take part in this clinical research?

"This clinical trial is enrolling up to 4700 patients diagnosed with carcinoma, hepatocellular and between 18-75 years old. Applicants must meet the following prerequisites: histology of liver biopsy results, radiological evidence of portal hypertension and cirrhosis related symptoms (e.g., gastroesophageal varices, ascites or hepatic encephalopathy), VCTE/Fibroscan evaluation showing a stiffness greater than 12.5kPa or magnetic resonance elastography > 5kPa; proof of current HCV infection, FIB-4 score no more than 3.25 in"

Answered by AI

Is the age criterion for enrolling in this research protocol set at 55 or older?

"Applicants aged between 18 and 75 are eligible to be part of this clinical trial. On the other hand, there are 36 studies designated for those younger than 18 years old and 864 trials specified for seniors over 65 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI

2023. "Preventing Liver Cancer Mortality Through Imaging With Ultrasound vs. MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05486572.

All > Liver Fibrosis > Hepatocellular Carcinoma