Hepatocellular CarcinomaNCT05429190
Validation of SMS Protocol for HCC Screening in High-risk Patients
An observational study of Hepatocellular Carcinoma, run by Erasmus Medical Center at 6 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Short MRI surveillance (SMS) protocol and Bi-annual ultrasonography screening
- Type of treatment
- Surgery or procedure
- How many people
- 470 participants
- Where
- 6 sitesNetherlands
- Study dates
- 7 Nov 2023to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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)
Who may be able to join
- Male and female patients above 18 years of age
- High-risk patients with cirrhosis and/or hepatitis
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Academic Medical Center
Amsterdam, North Holland, 1105AZ
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3318AT
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
St. Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, 3045PM
Maasstad Ziekenhuis
Rotterdam, South Holland, 3079DZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Short MRI surveillance (SMS) protocol, Bi-annual ultrasonography screening
- Keywords
- Cirrhosis, Hepatitis, Hepatocellular carcinoma, MRI, Surveillance
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short MRI surveillance (SMS) protocolRadiation
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 screeningRadiation
Bi-annual ultrasonography for screening of HCC in high-risk patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased sensitivity for HCC detection
Detection of HCC using the SMS protocol will be compared to US surveillance
Measured: 3 years
Secondary outcomes (1)
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start7 Nov 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline van de Braak, Erasmus Medical Center
- Investigators
- Prof. Dr. de Man, Principal investigator, Erasmus Medical CenterDr. Takkenberg, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Prof. Dr. Uyl-de Groot, Principal investigator, Erasmus School of Health Policy & Management RotterdamProf. Dr. IJzermans, Principal investigator, Erasmus Medical CenterDr. Bos, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429190
- Sponsor's protocol ID
- 2021-2 / 13803
- Status last verified
- Nov 2023
- First submitted
- 14 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Short and Effective MRI Surveillance (SMS) Protocol for Hepatocellular Carcinoma Screening in Practice
- ClinicalTrials.gov ID
- NCT05429190
- Acronym / sponsor ID
- 2021-2 / 13803
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Cirrhosis, Hepatitis, Hepatocellular carcinoma, MRI, Surveillance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- Male and female patients above 18 years of age
- High-risk patients with cirrhosis and/or hepatitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short MRI surveillance (SMS) protocolBi-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 | Radiation | – |
| Bi-annual ultrasonography screeningBi-annual ultrasonography for screening of HCC in high-risk patients | Radiation | – |
Primary outcome
Increased sensitivity for HCC detection
Time frame: 3 years
Detection of HCC using the SMS protocol will be compared to US surveillance
1 secondary outcome
Cost-effectiveness analysis of SMS protocol
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. de Man principal investigator
Erasmus Medical Center
Dr. Takkenberg principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prof. Dr. Uyl-de Groot principal investigator
Erasmus School of Health Policy & Management Rotterdam
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Erasmus Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased sensitivity for HCC detection (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.