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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05429190
• Other study ID #: 2021-2 / 13803
• Status: Enrolling by invitation
• Start date: November 7, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: November 2023
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 470
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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
• Bi-annual ultrasonography screening
Bi-annual ultrasonography for screening of HCC in high-risk patients

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid-Holland
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	Maasstad Ziekenhuis	Rotterdam	Zuid-Holland
Netherlands	St. Franciscus Gasthuis & Vlietland	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients acceptance of the SMS protocol (through a questionnaire)	Patients will be invited to circumvent their personal experiences, including confidence with both the SMS and US. The outcome may prove patients acceptance of SMS as the new standard for HCC surveillance.	3 years
Primary	Increased sensitivity for HCC detection	Detection of HCC using the SMS protocol will be compared to US surveillance	3 years
Secondary	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