CirrhosisNCT02854241
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance
A study testing Biannual ultrasonography, Annual noncontrast liver MRI and Contrast enhanced liver CT in people with Cirrhosis and Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cirrhosis, Hepatocellular Carcinoma
- What is being tested?
- Biannual ultrasonography, Annual noncontrast liver MRI and Contrast enhanced liver CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to Jun 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- equal to or older than 40 years
- under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
- risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
- signed informed consent
Who cannot join
- under 40 years
- history of HCC
- patients with pregnancy or nursing
- any contraindication of MRI
- any contraindication of CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis
The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.
Read the detailed description
The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.
- Conditions
- Cirrhosis, Hepatocellular Carcinoma
- Being tested
- Biannual ultrasonography, Annual noncontrast liver MRI, Contrast enhanced liver CT
- Keywords
- MRI, HCC, surveillance
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biannual ultrasonographyProcedure or surgery
Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
Annual noncontrast liver MRIProcedure or surgery
Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map.
DWI using multishot and T2 map are not included for initial MR reading.
Contrast enhanced liver CTProcedure or surgery
In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.
| Study group | Role | What they receive |
|---|---|---|
| LC group | Experimental | LC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC. Receives: Procedure: Biannual ultrasonography; Procedure: Annual noncontrast liver MRI; Procedure: Contrast enhanced liver CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity for detecting HCC
Measured: 6 months after last patient's MRI
Secondary outcomes (1)
specificity for detecting HCC
Measured: 6 months after last patient's MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT02854241
- Sponsor's protocol ID
- SNUH-2016-0174
- Status last verified
- Mar 2021
- First submitted
- 31 Jul 2016
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02854241
- Acronym / sponsor ID
- SNUH-2016-0174
- Conditions
- Cirrhosis, Hepatocellular Carcinoma
- Keywords
- MRI, HCC, surveillance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- 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 purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.
Detailed description
The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LC group | Experimental | Procedure: Biannual ultrasonography, Procedure: Annual noncontrast liver MRI, Procedure: Contrast enhanced liver CTLC group under surveillance of biannual ultrasonography and annual noncontrast liver MRI. Six month after the last MRI, contrast enhanced liver CT is performed to investigate presence of HCC. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- equal to or older than 40 years
- under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
- risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
- signed informed consent
Key exclusion criteria (5 listed)
- under 40 years
- history of HCC
- patients with pregnancy or nursing
- any contraindication of MRI
- any contraindication of CT
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 ultrasonographyBiannual ultrasonography for HCC surveillance, performed by board-certified radiologists. | Procedure or surgery | LC group |
| Annual noncontrast liver MRIAnnual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map. DWI using multishot and T2 map are not included for initial MR reading. | Procedure or surgery | LC group |
| Contrast enhanced liver CTIn patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan. | Procedure or surgery | LC group |
Primary outcome
sensitivity for detecting HCC
Time frame: 6 months after last patient's MRI
1 secondary outcome
specificity for detecting HCC
Time frame: 6 months after last patient's MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- 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 Min Lee, 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 Biannual ultrasonography, Annual noncontrast liver MRI and Contrast enhanced liver CT in people with Cirrhosis and 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 4 inclusion and 5 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 17 Mar 2021. 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?
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: 6 months after last patient's 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 17 Mar 2021.