Hepatocellular CarcinomaNCT05690451
Non-contrast Abbreviated MRI for Secondary Surveillance of HCC
An observational study of Hepatocellular Carcinoma, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- non-contrast abbreviated MRI and Contrast enhanced liver CT
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 28 Dec 2021to 22 Jun 2024
- How long will I take part?
- 24 Months
- 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 20 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent curative treatment for HCC including surgical resection or local ablation and have a more than a two-year disease-free period, needing continuous surveillance for the development of HCC will be candidates for this study.
Who may be able to join
- Age between 20-year old and 85-year old
- Patients with a history of curative treatment for HCC including surgical resection or local ablation
- No recurrence after curative treatment of HCC for more than two years
- Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)
Who cannot join
- Estimated GFR less than 60
- Previous history of severe allergic reaction to the iodinated contrast agent
- Patients with claustrophobia who can't undergo MR examination
- Patients having cochlear implants or cardiac pacemaker
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam, Korea (the Republic Of), 13620
Asan Medical Center
Seoul, Korea (the Republic Of), 05505
Seoul National University Hospital
Seoul, 03080
About this study
Official title: The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study
This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.
Read the detailed description
This study was designed as a prospective single-arm intra-individual comparison multicenter study
- Conditions
- Hepatocellular Carcinoma
- Being tested
- non-contrast abbreviated MRI, Contrast enhanced liver CT
- Keywords
- Secondary surveillance of hepatocellular carcinoma, Contrast enhanced liver CT, non-contrast abbreviated MRI
- 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 abbreviated MRIDiagnostic test
Liver MRI without contrast injection. The following sequences will be obtained from all of the participants.
- Axial heavily and regular T2 WI
- precontrast fat-suppressed T1 WI
- Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000
Contrast enhanced liver CTDiagnostic test
Liver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained
- precontast, arterial phase, portal venous phase and delayed phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy per patient
Accuracy for detection of recurrent HCC per patient
Measured: Within 6 months from the study completion
Secondary outcomes (2)
Specificity per patient
Specificity for detection of recurrent HCC per patient
Measured: Within 6 months from the study completion
Sensitivity per patient
Sensitivity for detection of recurrent HCC per patient
Measured: Within 6 months from the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start28 Dec 2021
- Primary completion22 Jun 2024
- Study completion22 Jun 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Ho Lee, Seoul National University Hospital
- Investigators
- Dong Ho Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690451
- Sponsor's protocol ID
- H-2106-183-1230
- Other IDs
- KCT0006395
- Status last verified
- Jun 2024
- First submitted
- 28 Dec 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) of this study will be available for reasonable requests after approval of IRB
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT05690451
- Acronym / sponsor ID
- H-2106-183-1230
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Secondary surveillance of hepatocellular carcinoma, Contrast enhanced liver CT, non-contrast abbreviated MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 19 Jan 2023 (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 prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.
Detailed description
This study was designed as a prospective single-arm intra-individual comparison multicenter study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent curative treatment for HCC including surgical resection or local ablation and have a more than a two-year disease-free period, needing continuous surveillance for the development of HCC will be candidates for this study.
Key inclusion criteria (4 listed)
- Age between 20-year old and 85-year old
- Patients with a history of curative treatment for HCC including surgical resection or local ablation
- No recurrence after curative treatment of HCC for more than two years
- Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)
Key exclusion criteria (4 listed)
- Estimated GFR less than 60
- Previous history of severe allergic reaction to the iodinated contrast agent
- Patients with claustrophobia who can't undergo MR examination
- Patients having cochlear implants or cardiac pacemaker
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 abbreviated MRILiver MRI without contrast injection. The following sequences will be obtained from all of the participants. * Axial heavily and regular T2 WI * precontrast fat-suppressed T1 WI * Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000 | Diagnostic test | – |
| Contrast enhanced liver CTLiver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained * precontast, arterial phase, portal venous phase and delayed phase | Diagnostic test | – |
Primary outcome
Accuracy per patient
Time frame: Within 6 months from the study completion
Accuracy for detection of recurrent HCC per patient
2 secondary outcomes
Specificity per patient
Time frame: Within 6 months from the study completion
Sensitivity per patient
Time frame: Within 6 months from the study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) of this study will be available for reasonable requests after approval of IRB
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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.
Dong Ho Lee, M.D. principal investigator
Seoul National University Hospital
3 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 Seoul National University Hospital at 3 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: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy per patient (time frame: Within 6 months from the study completion). 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 25 Jun 2024.