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Alternative Surveillance Program for Patients With High Risk Group of HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Non-contrast focused MRI

About this trial

This is an interventional screening trial for Hepatocellular Carcinoma focused on measuring US, MRI, HCC, surveillance, risk estimation

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

US & MRI

Arm Description

All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

diagnostic yield for HCC

HCC incidence in the group and detection rate with either US or focused MRI

scan time of focused MRI

in room time, table time are manually recorded

comparison between false referral rates of biannual US and annual focused MRI

comparison between false positive report/finding for HCC in each surveillance modality.

Full Information

NCT ID

NCT05657249

First Posted

December 10, 2022

Last Updated

January 6, 2023

Sponsor

Seoul National University Hospital

Collaborators

Severance Hospital, The Catholic University of Korea, Korea University Guro Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05657249

Brief Title

Alternative Surveillance Program for Patients With High Risk Group of HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 6, 2023 (Actual)

Primary Completion Date

February 28, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Severance Hospital, The Catholic University of Korea, Korea University Guro Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

US, MRI, HCC, surveillance, risk estimation

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

199 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

US & MRI

Arm Type

Experimental

Arm Description

All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.

Intervention Type

Diagnostic Test

Intervention Name(s)

Non-contrast focused MRI

Other Intervention Name(s)

Focused MRI, Abbreviated MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection

Description

per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

Time Frame

up to one year

Secondary Outcome Measure Information:

Title

Comparison of annual focused MRI and biannual US for HCC detection

Description

per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.

Time Frame

up to one year

Title

diagnostic yield for HCC

Description

HCC incidence in the group and detection rate with either US or focused MRI

Time Frame

up to one year

Title

scan time of focused MRI

Description

in room time, table time are manually recorded

Time Frame

up to one month

Title

comparison between false referral rates of biannual US and annual focused MRI

Description

comparison between false positive report/finding for HCC in each surveillance modality.

Time Frame

up to one year

Other Pre-specified Outcome Measures:

Title

comparison between incidental findings between biannual US and annual focused MRI

Description

comparison of incidental findings detected between biannual US and annual focused MRI.

Time Frame

up to one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

EunJung Choi, RN

Phone

82-2-2072-4177

eunjung0213@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Jeong Hee Yoon, MD

Phone

82-2-2072-2293

cinamon1@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeong Hee Yoon, MD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eunjung Choi, RN

Phone

82-2-2072-4177

eunjung0213@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Jeong Hee Yoon, MD

Phone

82-2-2072-2293

cinamon1@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Jeong Hee Yoon, MD

12. IPD Sharing Statement

Plan to Share IPD

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Alternative Surveillance Program for Patients With High Risk Group of HCC

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