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Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05690451
Enrollment
210
Registered
2023-01-19
Start date
2021-12-28
Completion date
2024-06-22
Last updated
2024-06-25

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

Conditions

Hepatocellular Carcinoma

Keywords

Secondary surveillance of hepatocellular carcinoma, Contrast enhanced liver CT, non-contrast abbreviated MRI

Brief summary

This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

Detailed description

This study was designed as a prospective single-arm intra-individual comparison multicenter study

Interventions

DIAGNOSTIC_TESTnon-contrast abbreviated MRI

Liver MRI without contrast injection. The following sequences will be obtained from all of the participants. * Axial heavily and regular T2 WI * precontrast fat-suppressed T1 WI * Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000

Liver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained * precontast, arterial phase, portal venous phase and delayed phase

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years

Inclusion criteria

* Age between 20-year old and 85-year old * Patients with a history of curative treatment for HCC including surgical resection or local ablation * No recurrence after curative treatment of HCC for more than two years * Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion criteria

* Estimated GFR less than 60 * Previous history of severe allergic reaction to the iodinated contrast agent * Patients with claustrophobia who can't undergo MR examination * Patients having cochlear implants or cardiac pacemaker

Design outcomes

Primary

MeasureTime frameDescription
Accuracy per patientWithin 6 months from the study completionAccuracy for detection of recurrent HCC per patient

Secondary

MeasureTime frameDescription
Specificity per patientWithin 6 months from the study completionSpecificity for detection of recurrent HCC per patient
Sensitivity per patientWithin 6 months from the study completionSensitivity for detection of recurrent HCC per patient

Countries

South Korea

Outcome results

None listed

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