Clinical trial · Interventional
Alternative Surveillance Program for Patients With High Risk Group of HCC
Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC
NCT05657249CI-TRIAL-00089764active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-contrast focused MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- US & MRI
- description
- All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI.
- interventionNames
- Diagnostic Test: Non-contrast focused MRI
Primary outcomes (1)
- measure
- Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
- timeFrame
- up to one year
- description
- per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
Secondary outcomes (4)
- measure
- Comparison of annual focused MRI and biannual US for HCC detection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * chronic hepatitis B or C * Child-Pugh classification A * HCC risk score \>= -2.04 * have not diagnosed with HCC * on surveillance program using US and negative on previous US within 6-8 months of enrollment * sign informed consent Exclusion Criteria: * younger than 40 years or older than 70 years old * history of HCC * severe GFR or on HD/PD due to renal failure * contra-indication of MRI * congestive hepatopathy * iron deposition * pregnancy or nursing mother * non-viral hepatitis or liver cirrhosis
References
Publications (0)
Data not yet available
No reference posted for this study.