Abbreviated MRI for HCC Surveillance

N/AUnknownNCT03731923

Seoul National University Hospital257 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

257

Conditions

Hepatocellular Carcinoma Liver Cirrhosis Chronic Hepatitis

Interventions

Biannual ultrasonographyDIAGNOSTIC_TEST

Biannual liver ultrasonography for HCC surveillance, without contrast agent.

Annual abbreviated liver MRIDIAGNOSTIC_TEST

Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Seoul National University Hospital

Seoul, South Korea

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

Seoul, South Korea

Outcomes

Primary Outcomes

Sensitivity for detecting HCC

Time frame: 12 months after last MRI

Secondary Outcomes

Table time of abbreviated MRI

time from scan start and scan end

Time frame: 1 day after each MRI

In-room time of abbreviated MRI

interval between participants' walk-in and walk-out times

Time frame: 1 day after each MRI

Specificity for detecting HCC

Time frame: 12 months after last MRI

Sensitivity for detecting early stage HCC

Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)

Time frame: 12 months after last MRI

Specificity for detecting early stage HCC

Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)

Time frame: 12 months after last MRI

Image quality of abbreviated liver MRI

qualitative analysis on four-point scale

Time frame: 12 months after last MRI

Data from ClinicalTrials.gov

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