Clinical trial NCT05429190: Validation of SMS Protocol for HCC Screening in High-risk Patients
Official title: Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma
Keywords: Cirrhosis
Hepatitis
Hepatocellular carcinoma
MRI
Surveillance
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with high-risk (cirrhosis and/or hepatitis) of developing HCC conform Dutch guidelines for HCC surveillance (https://www.oncoline.nl/hepatocellulair-carcinoom)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increased sensitivity for HCC detection
timeFrame: 3 years
Secondary outcomes:
measure: Cost-effectiveness analysis of SMS protocol
timeFrame: 2 years
Other outcomes:
measure: Patients acceptance of the SMS protocol (through a questionnaire)
timeFrame: 3 years
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: St. Franciscus Gasthuis & Vlietland
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Prof. Dr. de Man
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Dr. Takkenberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus School of Health Policy & Management Rotterdam
name: Prof. Dr. Uyl-de Groot
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Prof. Dr. IJzermans
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Dr. Bos
role: PRINCIPAL_INVESTIGATOR
References: