Delta Radiomics for Liver Function Evaluation

• Conditions: Chronic Liver Disease

• Registration Number: NCT05296434
• Lead Sponsor: Zhujiang Hospital

Brief Summary

To evaluate the feasibility and efficacy of delta radiomics-derived index based on Gd-EOB-DTPA enhanced MRI as a new imaging biomarker for the quantitative assessment of liver function.

Detailed Description

Delta radiomics is a novel concept proposed on the basis of radiomics. It can be used to evaluate the dynamic changes of imaging features in the time dimension, reflecting functional information of the tissue.

In clinical practice, liver function can be evaluated by gadoxate enhanced MRI by measuring signal intensity. Most often, simple visual assessment is performed, but quantitative measurements are also done. Theoretically, liver function should also be possible to quantify by using delta radiomics, ie by subtracting MR imaging features obtained in the earlier phase from the latter phase.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Study First Posted: 2022-03-25
• Last Update Posted: 2022-03-25
• Study Start: 2022-04-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-70 years old, no gender limit.
• Patients with chronic liver disease and different degrees of liver damage (Child-Pugh A, B and C) and healthy controls.
• No history of liver-related surgery (except for cholecystectomy).
• No cardiopulmonary diseases or other diseases which may impair liver function.
• Agree to participate in the study and provide written informed consent.

Exclusion Criteria

• Alcoholic hepatitis, non-alcoholic fatty liver disease, or autoimmune hepatitis.
• Liver tumors or metastasis or other extraheptic tumor.
• Splenectomy or other cases where the spleen is absent.
• Chronic kidney disease, renal damage.
• Allergy to contrast agents or other conditions that cannot undergo Gd-EOB-DTPA enhanced MRI exam.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between delta radiomics parameter and ICG test in assessment of liver function	within 3 days	MRI and ICG tests performed within 3 days apart

Secondary Outcome Measures

Name	Time	Method
Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function	with 3 days	MRI and blood biochemical tests performed within 3 days apart

Trial Locations

Locations (1)

The First Department of Hepatobiliary Surgery, Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China