Clinical trial · Observational
Validation of SMS Protocol for HCC Screening in High-risk Patients
Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice
NCT05429190CI-TRIAL-00071824unknownClinicalTrials.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)
The investigators will assess implementation of the proposed SMS protocol as a surveillance tool in patients at high risk of developing HCC in a prospective multicenter study.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bi-annual ultrasonography screening | Radiation | — | UNRESOLVED |
| Short MRI surveillance (SMS) protocol | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Increased sensitivity for HCC detection
- timeFrame
- 3 years
- description
- Detection of HCC using the SMS protocol will be compared to US surveillance
Secondary outcomes (1)
- measure
- Cost-effectiveness analysis of SMS protocol
- timeFrame
- 2 years
- description
- A cost-effectiveness analysis will be performed for the SMS protocol by measuring all direct medical costs. Using a Markov Model, the final outcome will give us an incremental cost-effectiveness ratio. Although direct costs of MRI (SMS protocol) are higher than US, improved detection of early HCC with SMS may finally prove more cost-effective than US
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients above 18 years of age * High-risk patients with cirrhosis and/or hepatitis Exclusion Criteria: * Patients below the age of 18 years * Patients who will not sign the informed consent form * Patients with general contra-indications for undergoing MRI examination
References
Publications (0)
Data not yet available
No reference posted for this study.