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Brief Title: 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 ID: NCT05429190
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Academic Medical Center, Amsterdam, Noord-Holland, Netherlands
Medisch Spectrum Twente, Enschede, Overijssel, Netherlands
Albert Schweitzer Ziekenhuis, Dordrecht, Zuid-Holland, Netherlands
Erasmus Medical Center, Rotterdam, Zuid-Holland, Netherlands
St. Franciscus Gasthuis & Vlietland, Rotterdam, Zuid-Holland, Netherlands
Maasstad Ziekenhuis, Rotterdam, Zuid-Holland, Netherlands
Name: Prof. Dr. de Man
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Takkenberg
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
Name: Prof. Dr. Uyl-de Groot
Affiliation: Erasmus School of Health Policy & Management Rotterdam
Role: PRINCIPAL_INVESTIGATOR
Name: Prof. Dr. IJzermans
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Dr. Bos
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR