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

NCT ID: NCT05429190

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2026-06-01

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type RADIATION

Bi-annual ultrasonography screening

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Céline van de Braak

PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof. Dr. de Man

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Dr. Takkenberg

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Prof. Dr. Uyl-de Groot

Role: PRINCIPAL_INVESTIGATOR

Erasmus School of Health Policy & Management Rotterdam

Prof. Dr. IJzermans

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Dr. Bos

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Academic Medical Center

Amsterdam, North Holland, Netherlands

Site Status

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Site Status

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Site Status

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status

St. Franciscus Gasthuis & Vlietland

Rotterdam, South Holland, Netherlands

Site Status

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2021-2 / 13803

Identifier Type: -

Identifier Source: org_study_id