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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05429190
Other study ID # 2021-2 / 13803
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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