Delta Radiomics for Liver Function Evaluation

Chronic Liver Disease Clinical Trial

Official title:

Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05296434
• Other study ID #: 2021-KY-105-02
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Zhujiang Hospital
• Contact: Yingfang Fan, MD,PhD
• Phone: 86-13189097816
• Email: fanxifan[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
China	The First Department of Hepatobiliary Surgery, Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between delta radiomics parameter and ICG test in assessment of liver function	MRI and ICG tests performed within 3 days apart	within 3 days
Secondary	Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function	MRI and blood biochemical tests performed within 3 days apart	with 3 days