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

November 24, 2023 updated by: Céline van de Braak, Erasmus Medical Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

470

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Academic Medical Center
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7512KZ
        • Medisch Spectrum Twente
    • Zuid-Holland
      • Dordrecht, Zuid-Holland, Netherlands, 3318AT
        • Albert Schweitzer Ziekenhuis
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Erasmus Medical Center
      • Rotterdam, Zuid-Holland, Netherlands, 3045PM
        • St. Franciscus Gasthuis & Vlietland
      • Rotterdam, Zuid-Holland, Netherlands, 3079DZ
        • Maasstad Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased sensitivity for HCC detection
Time Frame: 3 years
Detection of HCC using the SMS protocol will be compared to US surveillance
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness analysis of SMS protocol
Time Frame: 2 years
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients acceptance of the SMS protocol (through a questionnaire)
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Investigators

  • Principal Investigator: Prof. Dr. de Man, Erasmus Medical Center
  • Principal Investigator: Dr. Takkenberg, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Principal Investigator: Prof. Dr. Uyl-de Groot, Erasmus School of Health Policy & Management Rotterdam
  • Principal Investigator: Prof. Dr. IJzermans, Erasmus Medical Center
  • Principal Investigator: Dr. Bos, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-2 / 13803

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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