Chronic Liver DiseaseNCT05296434
Delta Radiomics for Liver Function Evaluation
An observational study of Chronic Liver Disease, run by Zhujiang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients with different degrees of liver function impairment.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
The First Department of Hepatobiliary Surgery, Zhujiang Hospital
Guangzhou, Guangdong, 510280
Yingfang Fan, MD,PhD, 86-13189097816, fanxifan@smu.edu.cn
About this study
Official title: Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function
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.
Read the 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.
- Conditions
- Chronic Liver Disease
- Keywords
- liver function, magnetic resonance imaging, radiomics, chronic liver disease, quantitative assement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests | |
| Child-Pugh A Group | Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests | |
| Child-Pugh B Group | Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests | |
| Child-Pugh C Group | Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between delta radiomics parameter and ICG test in assessment of liver function
MRI and ICG tests performed within 3 days apart
Measured: within 3 days
Secondary outcomes (1)
Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function
MRI and blood biochemical tests performed within 3 days apart
Measured: with 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfang Fan, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296434
- Sponsor's protocol ID
- 2021-KY-105-02
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delta Radiomics Based on Gd-EOB-DTPA-enhanced MRI for Quantitative Evaluation of Liver Function
- ClinicalTrials.gov ID
- NCT05296434
- Acronym / sponsor ID
- 2021-KY-105-02
- Conditions
- Chronic Liver Disease
- Keywords
- liver function, magnetic resonance imaging, radiomics, chronic liver disease, quantitative assement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Healthy volunteers undergoing MRI exam, ICG test and blood biochemical tests |
| Child-Pugh A Group | – | –Composed of patients with liver function of Child-Pugh A grade undergoing MRI exam, ICG test and blood biochemical tests |
| Child-Pugh B Group | – | –Composed of patients with liver function of Child-Pugh B grade undergoing MRI exam,ICG test and blood biochemical tests |
| Child-Pugh C Group | – | –Composed of patients with liver function of Child-Pugh C grade undergoing MRI exam |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with different degrees of liver function impairment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between delta radiomics parameter and ICG test in assessment of liver function
Time frame: within 3 days
MRI and ICG tests performed within 3 days apart
1 secondary outcome
Correlation between delta radiomics parameter and serum biochemical tests in assessment of liver function
Time frame: with 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Disease, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingfang Fan, MD,PhD (86-13189097816, fanxifan@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between delta radiomics parameter and ICG test in assessment of liver function (time frame: within 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.