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Diagnostic Test

Enhanced Screening for Liver Cancer

Phase 2
Recruiting
Led By George Ioannou, MD, MS
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-75
Cirrhosis, any etiology, or chronic HBV infection
Must not have
Prior receipt of any organ transplantation
Prior diagnosis of HCC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding MRI to the standard ultrasound + AFP screening for hepatocellular carcinoma (HCC) is more effective than the standard screening alone.

Who is the study for?
This trial is for American Indian and Alaska Native individuals aged 18-75 with liver cirrhosis or chronic Hepatitis B, who are at high risk of developing liver cancer. They must be able to give informed consent. Those with a prior diagnosis of liver cancer, severe liver dysfunction, kidney issues, contraindication to MRI, or pregnancy cannot participate.
What is being tested?
The study compares two methods of screening for liver cancer: ultrasound plus Alpha-Fetoprotein (AFP) testing versus abbreviated MRI plus AFP testing every six months over a year in patients at high risk for hepatocellular carcinoma.
What are the potential side effects?
Potential side effects from the interventions may include discomfort during imaging procedures and anxiety related to screening results. The contrast agent used in MRI might cause allergic reactions or other side effects in some people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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I have cirrhosis or a chronic hepatitis B infection.
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I understand and can agree to the study's procedures and risks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received an organ transplant.
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I have been diagnosed with liver cancer before.
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I am currently suspected to have liver cancer.
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My kidney function is low.
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I cannot attend all required study visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compliance with screening protocol
Feasibility of screening protocol

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: aMRI + AFPActive Control1 Intervention
Screening by abbreviated MRI of the abdomen + serum AFP testing at 0, 6 and 12 months
Group II: Ultrasound + AFPActive Control1 Intervention
Screening by abdominal ultrasound + serum AFP testing at 0, 6 and 12 months

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,860 Total Patients Enrolled
12 Trials studying Hepatitis B
14,735 Patients Enrolled for Hepatitis B
University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,183 Total Patients Enrolled
1 Trials studying Hepatitis B
19 Patients Enrolled for Hepatitis B
Cherokee Nation Health ServicesUNKNOWN
1 Previous Clinical Trials
190 Total Patients Enrolled

Media Library

Abbreviated MRI (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05304234 — Phase 2
Hepatitis B Research Study Groups: aMRI + AFP, Ultrasound + AFP
Hepatitis B Clinical Trial 2023: Abbreviated MRI Highlights & Side Effects. Trial Name: NCT05304234 — Phase 2
Abbreviated MRI (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304234 — Phase 2
~44 spots leftby Sep 2025
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