Quantitative CT Imaging Parameters for Assessing Hepatic Steatosis in CHB

NCT06616103 | Not Yet Recruiting

• 2 other identifiers: CHB prospective MEDIPRS-2023-00253896
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis B; Steatosis of Liver; Fibrosis and Cirrhosis of Liver

Outcome Measures

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

  At the time of enrollment

Secondary Outcomes (1)

• Consistency between MRI-derived body composition data and CT-derived data

  At the time of enrollment

Interventions

computerized tomography DIAGNOSTIC_TEST

noncontrast abdominal CT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Fatty Liver; Fibrosis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 27, 2024
• Study Start: September 26, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

KR (1)