Alternative Surveillance Program for Patients With High Risk Group of HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05657249
• Other study ID #: SNUH-2021-1084
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 199
• Est. completion date: December 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• chronic hepatitis B or C

• Child-Pugh classification A

• HCC risk score >= -2.04

• have not diagnosed with HCC

• on surveillance program using US and negative on previous US within 6-8 months of enrollment

• sign informed consent

Exclusion Criteria:

• younger than 40 years or older than 70 years old

• history of HCC

• severe GFR or on HD/PD due to renal failure

• contra-indication of MRI

• congestive hepatopathy

• iron deposition

• pregnancy or nursing mother

• non-viral hepatitis or liver cirrhosis

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• Non-contrast focused MRI
non-contrast liver MRI focusing on HCC surveillance in a short scan time.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea University Guro Hospital, Severance Hospital, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	comparison between incidental findings between biannual US and annual focused MRI	comparison of incidental findings detected between biannual US and annual focused MRI.	up to one year
Primary	Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection	per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.	up to one year
Secondary	Comparison of annual focused MRI and biannual US for HCC detection	per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.	up to one year
Secondary	diagnostic yield for HCC	HCC incidence in the group and detection rate with either US or focused MRI	up to one year
Secondary	scan time of focused MRI	in room time, table time are manually recorded	up to one month
Secondary	comparison between false referral rates of biannual US and annual focused MRI	comparison between false positive report/finding for HCC in each surveillance modality.	up to one year