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

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT05429190
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Status Verified: 2023-11
• Study Start: 2023-11-07
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 470

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increased sensitivity for HCC detection	3 years	Detection of HCC using the SMS protocol will be compared to US surveillance

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness analysis of SMS protocol	2 years	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

Trial Locations

Locations (6)

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Zuid-Holland, Netherlands

St. Franciscus Gasthuis & Vlietland; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Overijssel, Netherlands