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Delta Radiomics for Liver Function Evaluation

Z

Zhujiang Hospital

Status

Unknown

Conditions

Chronic Liver Disease

Study type

Observational

Funder types

Other

Identifiers

NCT05296434
2021-KY-105-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

60 participants in 4 patient groups

Control Group
Description:
Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests
Child-Pugh A Group
Description:
Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests
Child-Pugh B Group
Description:
Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests
Child-Pugh C Group
Description:
Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam

Trial contacts and locations

1

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Central trial contact

Xiaojun Hu, MD; Yingfang Fan, MD,PhD

Data sourced from clinicaltrials.gov

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