Alternative Surveillance Program for Patients With High Risk Group of HCC

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05657249

Enrollment

199

Registered

2022-12-20

Start date

2023-01-06

Completion date

2026-12-31

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

US, MRI, HCC, surveillance, risk estimation

Brief 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

Interventions

DIAGNOSTIC_TESTNon-contrast focused MRI

non-contrast liver MRI focusing on HCC surveillance in a short scan time.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection	up to one year	per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

Secondary

Measure	Time frame	Description
Comparison of annual focused MRI and biannual US for HCC detection	up to one year	per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
diagnostic yield for HCC	up to one year	HCC incidence in the group and detection rate with either US or focused MRI
scan time of focused MRI	up to one month	in room time, table time are manually recorded
comparison between false referral rates of biannual US and annual focused MRI	up to one year	comparison between false positive report/finding for HCC in each surveillance modality.

Other

Measure	Time frame	Description
comparison between incidental findings between biannual US and annual focused MRI	up to one year	comparison of incidental findings detected between biannual US and annual focused MRI.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026