Chronic Hepatitis BNCT06616103
Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB
An observational study of Chronic Hepatitis B and Steatosis of Liver, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Hepatitis B, Steatosis of Liver, Fibrosis and Cirrhosis of Liver
- What is being tested?
- computerized tomography
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2024to 31 Aug 2025
- How long will I take part?
- 1 Year
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis B who follow up at Seoul National University Hospital having no history of hepatic malignancies
Who may be able to join
- chronic hepatitis B
- no chronic liver disease other than chronic hepatitis B
- Body mass index \>= 23
Who cannot join
- pregnant women
- unable to perform MRI examinations due to claustrophobia or metallic foreign body
- suspicious hepatic malignancy on previous imaging studies
- history of local treatment for hepatic lesions
- history of surgery or catheter insertion of liver or spleen
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Jeongin Yoo, M.D., +82-220723107, jeongin527@snu.ac.kr
About this study
Official title: Utility of Quantitative Imaging Parameters from Deep Learning-based CT Segmentation in Assessing Hepatic Steatosis and Fibrosis in Chronic Hepatitis B: a Prospective Study Using MRI As the Reference Standard
This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.
- Being tested
- computerized tomography
- Medical subject headings
- Hepatitis B, Chronic, Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized tomographyDiagnostic test
noncontrast abdominal CT
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis
diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis using MRI-PDFF and MR elastography as reference standards
Measured: At the time of enrollment
Secondary outcomes (1)
Consistency between MRI-derived body composition data and CT-derived data
Consistency between MRI-derived body composition data and CT-derived data using automated 3D organ segmentation algorithm
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start26 Sep 2024 (estimated)
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies 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
- 111 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeongin Yoo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616103
- Sponsor's protocol ID
- CHB prospective MEDIP
- Other IDs
- RS-2023-00253896
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Quantitative Imaging Parameters from Deep Learning-based CT Segmentation in Assessing Hepatic Steatosis and Fibrosis in Chronic Hepatitis B: a Prospective Study Using MRI As the Reference Standard
- ClinicalTrials.gov ID
- NCT06616103
- Acronym / sponsor ID
- CHB prospective MEDIP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 26 Sep 2024 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 27 Sep 2024 (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 evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis B who follow up at Seoul National University Hospital having no history of hepatic malignancies
Key inclusion criteria (3 listed)
- chronic hepatitis B
- no chronic liver disease other than chronic hepatitis B
- Body mass index \>= 23
Key exclusion criteria (5 listed)
- pregnant women
- unable to perform MRI examinations due to claustrophobia or metallic foreign body
- suspicious hepatic malignancy on previous imaging studies
- history of local treatment for hepatic lesions
- history of surgery or catheter insertion of liver or spleen
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 |
|---|---|---|
| computerized tomographynoncontrast abdominal CT | Diagnostic test | – |
Primary outcome
diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis
Time frame: At the time of enrollment
diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis using MRI-PDFF and MR elastography as reference standards
1 secondary outcome
Consistency between MRI-derived body composition data and CT-derived data
Time frame: At the time of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B and Steatosis of Liver, 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 3 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 27 Sep 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance of CT attenuatio parameters in assessing hepatic steatosis and fibrosis (time frame: At the time of enrollment). 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 27 Sep 2024.