NCT02854241

Brief Summary

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5.4 years

First QC Date

July 31, 2016

Last Update Submit

March 16, 2021

Conditions

CirrhosisHepatocellular Carcinoma

Keywords

MRIHCCsurveillance

Outcome Measures

Primary Outcomes (1)

  • sensitivity for detecting HCC

    6 months after last patient's MRI

Secondary Outcomes (1)

  • specificity for detecting HCC

    6 months after last patient's MRI

Other Outcomes (2)

  • Apparent diffusion coefficient (ADC)

    1 month after each MR scan

  • T2 relaxation time

    1 month after MR scan

Study Arms (1)

LC group

EXPERIMENTAL

LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC.

Procedure: Biannual ultrasonographyProcedure: Annual noncontrast liver MRIProcedure: Contrast enhanced liver CT

Interventions

Biannual ultrasonographyPROCEDURE

Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.

LC group
Annual noncontrast liver MRIPROCEDURE

Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map. DWI using multishot and T2 map are not included for initial MR reading.

LC group
Contrast enhanced liver CTPROCEDURE

In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.

LC group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • equal to or older than 40 years
  • under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
  • risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is \<=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is \<=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
  • signed informed consent

You may not qualify if:

  • under 40 years
  • history of HCC
  • patients with pregnancy or nursing
  • any contraindication of MRI
  • any contraindication of CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

FibrosisCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 31, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)