Delta Radiomics for Liver Function Evaluation

NCT ID: NCT05296434

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Liver Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests

No interventions assigned to this group

Child-Pugh A Group

Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests

No interventions assigned to this group

Child-Pugh B Group

Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests

No interventions assigned to this group

Child-Pugh C Group

Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yingfang Fan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Department of Hepatobiliary Surgery, Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yingfang Fan, MD,PhD

Role: CONTACT

86-13189097816

Xiaojun Hu, MD

Role: CONTACT

86-13925156062

Facility Contacts

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Yingfang Fan, MD,PhD

Role: primary

86-13189097816

Other Identifiers

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2021-KY-105-02

Identifier Type: -

Identifier Source: org_study_id

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