UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054302 |
|---|---|
| Receipt number | R000062025 |
| Scientific Title | Clinical Trial on Artificial Intelligence (AI) Assisted System for Diagnosis of Liver Lipidosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/02/17 19:21:07 |
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Basic information
Public title
Clinical Trial on Artificial Intelligence (AI) Assisted System for Diagnosis of Liver Lipidosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver
Acronym
Clinical Trial on Artificial Intelligence (AI) Assisted System for Diagnosis of Liver Lipidosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver
Scientific Title
Clinical Trial on Artificial Intelligence (AI) Assisted System for Diagnosis of Liver Lipidosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver
Scientific Title:Acronym
Clinical Trial on Artificial Intelligence (AI) Assisted System for Diagnosis of Liver Lipidosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver
Region
| Japan |
Condition
Condition
non-alcoholic fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Liver fibrosis/fatty degeneration by conventional abdominal ultrasonography is easily dependent on the examiner's skill and lacks objectivity and reproducibility. In this study, we will compare the quantification of liver fibrosis and fatty acid in abdominal ultrasonography using an AI-assisted system with that of ultrasound elastography and liver fibrosis markers and that of MRI to determine whether it is possible to assess liver fibrosis and fatty acid more conveniently in daily clinical practice. We will verify whether the assessment of liver fibrosis and lipidosis can be made easier in routine clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal ultrasound and MRI examinations are performed after consent forms are obtained. Abdominal ultrasound qualitatively and quantitatively evaluates the degree of liver fibrosis and lipidosis, while MRI quantifies and evaluates the amount of fat in the liver.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with liver disease or hepatic dysfunction
(2) Patients must be at least 20 years of age (regardless of gender).
(3) Patients must have been fully informed of the study and must have given written consent of their own free will.
Key exclusion criteria
1) Patients with tattoos or MRI-unsuitable metal in the body
2) Pregnant or lactating women, or patients who may be pregnant or intend to become pregnant (a pregnancy reaction test should be performed if pregnancy is suspected).
3) Patients with other conditions that may compromise patient safety in the conduct of the study or make it difficult to comply with the study protocol.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
gastroenterology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
unozawa.hidemi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Hidemi |
| Middle name | |
| Last name | Unozawa |
Organization
Chiba University Hospital
Division name
gastroenterology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
0432227171
Homepage URL
unozawa.hidemi@chiba-u.jp
Sponsor or person
Institute
Chiba university hospital
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba university hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
unozawa.hidemi@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Carotid Artery Echocardiographic Evaluation of Plaque and Stenosis and Correlation with Fatty Liver
Prevalence of cardiovascular events in fatty liver patients
Evaluation of fibrosis by B-mode and correlation with ultrasound elastography and fibrosis markers
Management information
Registered date
| 2024 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062025
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/05/30 | 20250530「非アルコール性脂肪肝患者における人工知能(AI)支援システムによる肝脂肪化・線維化診断に関する臨床試験」 (2).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/05/30 | 20250530「非アルコール性脂肪肝患者における人工知能(AI)支援システムによる肝脂肪化・線維化診断に関する臨床試験」 (2).docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/05/30 | 20250530 M10269 02_倫理研究実施（経過・終了）報告書.docx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/62025
