Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB

September 24, 2024 updated by: Jeongin Yoo, Seoul National University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the time of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency between MRI-derived body composition data and CT-derived data
Time Frame: At the time of enrollment
Consistency between MRI-derived body composition data and CT-derived data using automated 3D organ segmentation algorithm
At the time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 26, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB prospective MEDIP
  • RS-2023-00253896 (Other Grant/Funding Number: National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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