Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

Study Overview
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Brief Summary
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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
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This study was designed as a prospective single-arm intra-individual comparison multicenter study

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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Diagnostic Test: non-contrast abbreviated MRI
* Diagnostic Test: Contrast enhanced liver CT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: non-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|
|Diagnostic Test: Contrast enhanced liver CT|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy per patient | Accuracy for detection of recurrent HCC per patient | Within 6 months from the study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity per patient | Specificity for detection of recurrent HCC per patient | Within 6 months from the study completion | 
| Sensitivity per patient | Sensitivity for detection of recurrent HCC per patient | Within 6 months from the study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary surveillance of hepatocellular carcinoma, Contrast enhanced liver CT, non-contrast abbreviated MRI