ClinicalTrials.gg
Not yet recruitingNCT06616103Updated Sep 27, 2024

Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB

An observational study in Chronic Hepatitis B, Steatosis of Liver and Fibrosis and Cirrhosis of Liver, sponsored by Seoul National University Hospital. Not yet recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
111
Ages
19 Years and older
Sex
All
01

Study summary

This study aims to evaluate diagnostic performance of CT attenuation parameters acquired using deep learning algorithm in assessing hepatic steatosis and fibrosis.

02

Conditions studied

  • Chronic Hepatitis B
  • Steatosis of Liver
  • Fibrosis and Cirrhosis of Liver
03

In context

Hepatitis B, Chronic

895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.

This study's planned enrollment of 111 is below the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with chronic hepatitis B who follow up at Seoul National University Hospital having no history of hepatic malignancies

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • chronic
  • no chronic liver disease other than chronic hepatitis B
  • >= 23

Exclusion criteria

Exclusion Criteria:

  • pregnant women
  • unable to perform MRI examinations due to claustrophobia or metallic foreign body
  • suspicious hepatic on previous imaging studies
  • history of local treatment for hepatic lesions
  • history of surgery or catheter insertion of liver or spleen
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
111 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Diagnostic testcomputerized tomography

    noncontrast abdominal CT

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: At the time of enrollment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06616103
Responsible party
Jeongin Yoo (Clinical assistant professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 27, 2024
Start date
Sep 26, 2024 (estimated)
Primary completion
Aug 31, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Sep 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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