Delta Radiomics for Liver Function Evaluation

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05296434

Enrollment

Registered

2022-03-25

Start date

2022-04-01

Completion date

2022-12-31

Last updated

2022-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease

Keywords

liver function, magnetic resonance imaging, radiomics, chronic liver disease, quantitative assement

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYingfang Fan, MD,PhD

fanxifan@smu.edu.cn86-13189097816

Backup ContactXiaojun Hu, MD

huxj2016@163.com86-13925156062

Outcome results