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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05429190
Study type	Observational
Source	Erasmus Medical Center
Contact
Status	Enrolling by invitation
Phase
Start date	November 7, 2023
Completion date	June 1, 2026

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