Validation of SMS Protocol for HCC Screening in High-risk Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Over the past 20 years, the prevalence of HCC has been growing extensively. HCC makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. The incidence of HCC is higher in patients diagnosed with hepatitis and/or cirrhosis. The current guidelines recommend a bi-annual US screening of this patient group. However, recent meta-analysis showed that the sensitivity of such US surveillance for detecting early stage HCC is merely 47%. In addition, early detection of small HCC lesions (with a diameter less than 2 cm) will provide a higher survival chance. It is therefore of major importance to develop a better surveillance tool. The use of MRI should be considered as a surveillance tool for this patient group. In comparison to US, MRI come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. The investigators have developed and validated a short MRI surveillance (SMS) protocol for HCC screening in high-risk patients. This protocol has been evaluated among a database of 215 patients. In this prospective, multicenter study, the investigators will evaluate the value of the SMS protocol in a high-risk patient group and they will assess the cost-effectiveness of the SMS protocol as a surveillance tool with respect to a bi-annual US screening.

Official Title
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Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Short MRI surveillance (SMS) protocol
* Radiation: Bi-annual ultrasonography screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- |
|Radiation: Short MRI surveillance (SMS) protocol|Bi-annual, non-contrast agents, MRI screening consisting of Diffusion Weighted Imaging (b-values of 50 and 800 s/mm2), T2-weighted imaging and T1-weighted in- and out-of-phase imaging|
|Radiation: Bi-annual ultrasonography screening|Bi-annual ultrasonography for screening of HCC in high-risk patients|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased sensitivity for HCC detection | Detection of HCC using the SMS protocol will be compared to US surveillance | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness analysis of SMS protocol | 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Cirrhosis, Hepatitis, Hepatocellular carcinoma, Surveillance