Hepatocellular CarcinomaNCT05657249
Alternative Surveillance Program for Patients With High Risk Group of HCC
A study testing Non-contrast focused MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Non-contrast focused MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic hepatitis B or C
- Child-Pugh classification A
- HCC risk score >= -2.04
- have not diagnosed with HCC
- on surveillance program using US and negative on previous US within 6-8 months of enrollment
- sign informed consent
Who cannot join
- younger than 40 years or older than 70 years old
- history of HCC
- severe GFR or on HD/PD due to renal failure
- contra-indication of MRI
- congestive hepatopathy
- iron deposition
- pregnancy or nursing mother
- non-viral hepatitis or liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC
In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Non-contrast focused MRI
- Keywords
- US, MRI, HCC, surveillance, risk estimation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast focused MRIDiagnostic test
Also called Focused MRI, Abbreviated MRI
non-contrast liver MRI focusing on HCC surveillance in a short scan time.
| Study group | Role | What they receive |
|---|---|---|
| US & MRI | Experimental | All participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI. Receives: Diagnostic Test: Non-contrast focused MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
Measured: up to one year
Secondary outcomes (4)
Comparison of annual focused MRI and biannual US for HCC detection
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
Measured: up to one year
diagnostic yield for HCC
HCC incidence in the group and detection rate with either US or focused MRI
Measured: up to one year
scan time of focused MRI
in room time, table time are manually recorded
Measured: up to one month
comparison between false referral rates of biannual US and annual focused MRI
comparison between false positive report/finding for HCC in each surveillance modality.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Jan 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Dec 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 Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, The Catholic University of Korea, Korea University Guro Hospital
- Responsible party
- Principal investigator, Jeong Hee Yoon, Seoul National University Hospital
- Investigators
- Jeong Hee Yoon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657249
- Sponsor's protocol ID
- SNUH-2021-1084
- Status last verified
- May 2025
- First submitted
- 10 Dec 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternative Surveillance Program for Prospective Cohort of a Super-high Risk Group of Developing HCC
- ClinicalTrials.gov ID
- NCT05657249
- Acronym / sponsor ID
- SNUH-2021-1084
- Conditions
- Hepatocellular Carcinoma
- Keywords
- US, MRI, HCC, surveillance, risk estimation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, The Catholic University of Korea, Korea University Guro Hospital
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Dec 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.
In a high-risk group, ultrasonography at 6-month intervals and short-protocol magnetic resonance imaging at 1-year intervals were performed. sensitivity, specificity, positive and negative predictive values for very early stage HCC are compared between conventional (biannual US) and alternative surveillance test are compared
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| US & MRI | Experimental | Diagnostic Test: Non-contrast focused MRIAll participants undergo biannual US (as a part of standard-of-care) and annual non-contrast focused MRI. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- chronic hepatitis B or C
- Child-Pugh classification A
- HCC risk score >= -2.04
- have not diagnosed with HCC
- on surveillance program using US and negative on previous US within 6-8 months of enrollment
Key exclusion criteria (8 listed)
- younger than 40 years or older than 70 years old
- history of HCC
- severe GFR or on HD/PD due to renal failure
- contra-indication of MRI
- congestive hepatopathy
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 |
|---|---|---|
| Non-contrast focused MRIAlso: Focused MRI, Abbreviated MRInon-contrast liver MRI focusing on HCC surveillance in a short scan time. | Diagnostic test | US & MRI |
Primary outcome
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection
Time frame: up to one year
per-patient sensitivity, specificity, positive predictive value, negative predictive value for very early stage HCC, early stage HCC, all stage of HCC/liver cancer.
4 secondary outcomes
Comparison of annual focused MRI and biannual US for HCC detection
Time frame: up to one year
diagnostic yield for HCC
Time frame: up to one year
scan time of focused MRI
Time frame: up to one month
comparison between false referral rates of biannual US and annual focused MRI
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: No
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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.
Jeong Hee Yoon, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contrast focused MRI in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparison of alternative surveillance program (alternating focused MRI + US in 6 month interval) and conventional surveillance (biannual US) for HCC detection (time frame: up to one year). 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 15 May 2025.