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Abbreviated MRI for HCC Surveillance

Primary Purpose

Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biannual ultrasonography
Annual abbreviated liver MRI
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatocellular Carcinoma focused on measuring MRI, ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
  • no history of HCC
  • on surveillance of HCC using ultrasonography
  • sign informed consent

Exclusion Criteria:

  • history of HCC
  • congestive hepatopathy
  • iron deposition
  • any absolute or relative contra-indication of contrast-enhanced MRI

Sites / Locations

  • Seoul National University Hospital
  • The Catholic University of Korea, Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High risk group of HCC

Arm Description

High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI.

Outcomes

Primary Outcome Measures

Sensitivity for detecting HCC
Sensitivity for detecting HCC

Secondary Outcome Measures

Table time of abbreviated MRI
time from scan start and scan end
In-room time of abbreviated MRI
interval between participants' walk-in and walk-out times
Specificity for detecting HCC
Specificity for detecting HCC
Sensitivity for detecting early stage HCC
Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Specificity for detecting early stage HCC
Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Image quality of abbreviated liver MRI
qualitative analysis on four-point scale

Full Information

First Posted
November 4, 2018
Last Updated
August 16, 2023
Sponsor
Seoul National University Hospital
Collaborators
Guerbet
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1. Study Identification

Unique Protocol Identification Number
NCT03731923
Brief Title
Abbreviated MRI for HCC Surveillance
Official Title
MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Guerbet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis
Keywords
MRI, ultrasonography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High risk group of HCC
Arm Type
Experimental
Arm Description
High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biannual ultrasonography
Other Intervention Name(s)
liver USG
Intervention Description
Biannual liver ultrasonography for HCC surveillance, without contrast agent.
Intervention Type
Diagnostic Test
Intervention Name(s)
Annual abbreviated liver MRI
Other Intervention Name(s)
Abbreviated liver MRI
Intervention Description
Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.
Primary Outcome Measure Information:
Title
Sensitivity for detecting HCC
Description
Sensitivity for detecting HCC
Time Frame
12 months after last MRI
Secondary Outcome Measure Information:
Title
Table time of abbreviated MRI
Description
time from scan start and scan end
Time Frame
1 day after each MRI
Title
In-room time of abbreviated MRI
Description
interval between participants' walk-in and walk-out times
Time Frame
1 day after each MRI
Title
Specificity for detecting HCC
Description
Specificity for detecting HCC
Time Frame
12 months after last MRI
Title
Sensitivity for detecting early stage HCC
Description
Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Time Frame
12 months after last MRI
Title
Specificity for detecting early stage HCC
Description
Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Time Frame
12 months after last MRI
Title
Image quality of abbreviated liver MRI
Description
qualitative analysis on four-point scale
Time Frame
12 months after last MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis) no history of HCC on surveillance of HCC using ultrasonography sign informed consent Exclusion Criteria: history of HCC congestive hepatopathy iron deposition any absolute or relative contra-indication of contrast-enhanced MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Min Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Abbreviated MRI for HCC Surveillance

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