Hepatocellular CarcinomaNCT03731923
Abbreviated MRI for HCC Surveillance
A study testing Biannual ultrasonography and Annual abbreviated liver MRI in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis
- What is being tested?
- Biannual ultrasonography and Annual abbreviated liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 8 Nov 2018to 31 Dec 2023
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
- no history of HCC
- on surveillance of HCC using ultrasonography
- sign informed consent
Who cannot join
- history of HCC
- congestive hepatopathy
- iron deposition
- any absolute or relative contra-indication of contrast-enhanced MRI
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official title: MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group
This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis
- Being tested
- Biannual ultrasonography, Annual abbreviated liver MRI
- Keywords
- MRI, ultrasonography
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biannual ultrasonographyDiagnostic test
Also called liver USG
Biannual liver ultrasonography for HCC surveillance, without contrast agent.
Annual abbreviated liver MRIDiagnostic test
Also called Abbreviated liver MRI
Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| High risk group of HCC | Experimental | High risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI. Receives: Diagnostic Test: Biannual ultrasonography; Diagnostic Test: Annual abbreviated liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for detecting HCC
Sensitivity for detecting HCC
Measured: 12 months after last MRI
Secondary outcomes (6)
Table time of abbreviated MRI
time from scan start and scan end
Measured: 1 day after each MRI
In-room time of abbreviated MRI
interval between participants' walk-in and walk-out times
Measured: 1 day after each MRI
Specificity for detecting HCC
Specificity for detecting HCC
Measured: 12 months after last MRI
Sensitivity for detecting early stage HCC
Sensitivity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Measured: 12 months after last MRI
Specificity for detecting early stage HCC
Specificity for detecting early stage HCC (≤3cm, ≤3 tumors, or ≤5cm single tumor)
Measured: 12 months after last MRI
Image quality of abbreviated liver MRI
qualitative analysis on four-point scale
Measured: 12 months after last MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start8 Nov 2018
- Primary completion15 Dec 2021
- Study completion31 Dec 2023 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731923
- Sponsor's protocol ID
- SNUH-2018-1426
- Status last verified
- Aug 2023
- First submitted
- 4 Nov 2018
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group
- ClinicalTrials.gov ID
- NCT03731923
- Acronym / sponsor ID
- SNUH-2018-1426
- Conditions
- Hepatocellular Carcinoma, Liver Cirrhosis, Chronic Hepatitis
- Keywords
- MRI, ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Nov 2018 (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.
This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High risk group of HCC | Experimental | Diagnostic Test: Biannual ultrasonography, Diagnostic Test: Annual abbreviated liver MRIHigh risk group of HCC with chronic hepatitis or liver cirrhosis. Participants undergo biannual ultrasonography and annual abbreviated liver MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)
- no history of HCC
- on surveillance of HCC using ultrasonography
- sign informed consent
Key exclusion criteria (4 listed)
- history of HCC
- congestive hepatopathy
- iron deposition
- any absolute or relative contra-indication of contrast-enhanced MRI
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 |
|---|---|---|
| Biannual ultrasonographyAlso: liver USGBiannual liver ultrasonography for HCC surveillance, without contrast agent. | Diagnostic test | High risk group of HCC |
| Annual abbreviated liver MRIAlso: Abbreviated liver MRIAbbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes. | Diagnostic test | High risk group of HCC |
Primary outcome
Sensitivity for detecting HCC
Time frame: 12 months after last MRI
Sensitivity for detecting HCC
6 secondary outcomes
Table time of abbreviated MRI
Time frame: 1 day after each MRI
In-room time of abbreviated MRI
Time frame: 1 day after each MRI
Specificity for detecting HCC
Time frame: 12 months after last MRI
Sensitivity for detecting early stage HCC
Time frame: 12 months after last MRI
Specificity for detecting early stage HCC
Time frame: 12 months after last MRI
Image quality of abbreviated liver MRI
Time frame: 12 months after last MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: No
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Not yet recruitingPhase 2
Study Evaluating the Efficacy and Safety of BGB-B2033 in Participants With Advanced Hepatocellular Carcinoma
Hepatocellular Cancer, Liver Cancer
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Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Not yet recruitingObservational study
Integration of Imaging, Molecular, Pathological, and Clinical Outcome Data in Hepatocellular Carcinoma.
Resectable Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
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 Min Lee, MD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biannual ultrasonography and Annual abbreviated liver MRI in people with Hepatocellular Carcinoma and Liver Cirrhosis, run by Seoul National University Hospital at 2 sites 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 4 inclusion and 4 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 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Sensitivity for detecting HCC (time frame: 12 months after last MRI). 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 18 Aug 2023.