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Abbreviated MRI for HCC Surveillance

MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03731923
Enrollment
257
Registered
2018-11-06
Start date
2018-11-08
Completion date
2023-12-31
Last updated
2023-08-18

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

Conditions

Chronic Hepatitis, Hepatocellular Carcinoma, Liver Cirrhosis

Keywords

MRI, ultrasonography

Brief summary

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

Interventions

DIAGNOSTIC_TESTBiannual ultrasonography

Biannual liver ultrasonography for HCC surveillance, without contrast agent.

DIAGNOSTIC_TESTAnnual abbreviated liver MRI

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

Sponsors

Guerbet
CollaboratorINDUSTRY
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity for detecting HCC12 months after last MRISensitivity for detecting HCC

Secondary

MeasureTime frameDescription
In-room time of abbreviated MRI1 day after each MRIinterval between participants' walk-in and walk-out times
Specificity for detecting HCC12 months after last MRISpecificity for detecting HCC
Table time of abbreviated MRI1 day after each MRItime from scan start and scan end
Specificity for detecting early stage HCC12 months after last MRISpecificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Image quality of abbreviated liver MRI12 months after last MRIqualitative analysis on four-point scale
Sensitivity for detecting early stage HCC12 months after last MRISensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)

Countries

South Korea

Outcome results

None listed

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