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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compliance with screening protocol
Feasibility of screening protocol

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
13,665 Previous Clinical Trials
40,925,654 Total Patients Enrolled
16 Trials studying Liver Cirrhosis
11,533 Patients Enrolled for Liver Cirrhosis
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,566 Total Patients Enrolled
4 Trials studying Liver Cirrhosis
5,284 Patients Enrolled for Liver Cirrhosis
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
Liver Cirrhosis Research Study Groups: aMRI + AFP, Ultrasound + AFP
Liver Cirrhosis 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

Frequently Asked Questions

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

How many people are allowed to be a part of this experiment?

"The listing on clinicaltrials.gov suggests that this is an ongoing trial which began recruitment on April 1st, 2020. The study is looking for 200 participants from a single site."

Answered by AI

Are there any patients who have not yet been enrolled in this clinical trial?

"The study is still recruiting patients, according to the most recent information available on clinicaltrials.gov. This research was first made public on April 1st, 2022 and received its last update June 13th of the same year."

Answered by AI

Does the FDA approve of using ultrasound in combination with AFP testing?

"As this is a Phase 2 trial, meaning that while there are data supporting safety, none yet support efficacy, our team at Power have given Ultrasound + AFP a score of 2 for safety."

Answered by AI

Does this particular research project allow for senior citizens to enroll?

"This trial includes all patients that are between 18-75 years old."

Answered by AI

Would I be able to join this experiment?

"The hepatitis b clinical trial is looking for around 200 individuals who are aged between 18 and 75."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Cherokee Nation Health Service
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Liver Cancer Disparities in American Indian and Alaska Native Persons
George Ioannou 2022. "Liver Cancer Disparities in American Indian and Alaska Native Persons". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05304234.
All > Liver Cirrhosis > Hepatitis B
~67 spots leftby Apr 2025
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