UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041196 |
|---|---|
| Receipt number | R000047037 |
| Scientific Title | Multicentral study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) by comparison with MRI-determined proton density fat fraction (PDFF) |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2023/02/22 14:55:25 |
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Basic information
Public title
Multicentral study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) by comparison with MRI-determined proton density fat fraction (PDFF)
Acronym
Ultrasound-guided attenuation parameter (UGAP) study
Scientific Title
Multicentral study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) by comparison with MRI-determined proton density fat fraction (PDFF)
Scientific Title:Acronym
Ultrasound-guided attenuation parameter (UGAP) study
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of hepatic steatosis by UGAP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We assess the accuracy of UGAP in assessing hepatic steatosis compared to PDFF
Key secondary outcomes
We verify whether UGAP can diagnose fatty liver (liver fat content 5% or more)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who underwent UGAP and PDFF within 3 months
2.Patients with chronic liver disease including viral hepatitis, NAFLD, autoimmune hepatitis, primary biliary cholangitis, and so on
3.Patients who can follow instructions such as breath-holding.
Key exclusion criteria
1.Patients without claustrophobia
2.Patients without magnetic substance or tattoo
3.Patients without pacemakers
4.Patients judged as inappropriate for the study by the study responsibility (share) physician.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hidenori |
| Middle name | |
| Last name | Toyoda |
Organization
Ogaki Municipal Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
5038502
Address
4-86 Minaminokawa-cho, Ogaki-shi, Gifu-ken
TEL
+81-584-81-3341
hmtoyoda@spice.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kumada |
| Middle name | |
| Last name | Takashi |
Organization
Gifu Kyoritsu University
Division name
Department of Nursing, Faculty of Nursing,
Zip code
5038550
Address
5-50, Kitagata-cho, Ogaki-shi, Gifu-ken
TEL
+81-584-77-3512
Homepage URL
takashi.kumada@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
GE Precision Healthcare
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Shinshu University School of Medicine, Department of Radiology
Nayoro City General Hospital, Department of Gastroenterology
Iwate Medical University,Division of Hepatology,Department of Internal Medicine
Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Musashino Red-Cross Hospital,Department of Gastroenterology and Hepatology
Tokyo Medical University, Department of Gastroenterology and Hepatology
Gifu Kyoritsu University, Department of Nursing
Saga University, Faculty of Medicine, Department of Pathology and Microbiology
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ogaki Municipal Hospital
Address
4-86 Minaminokawa, Ogaki, Gifu, Japan, 503-8502
Tel
+81-584-81-3341
clinical-trial@omh.ogaki.gifu.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
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34768008/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34768008/
Number of participants that the trial has enrolled
1010
Results
UGAP has excellent diagnostic accuracy for grading steatosis with reference to MRI-PDFF. Additionally, UGAP has good linearity and negligible bias, suggesting that UGAP has excellent technical performance characteristics that can be widely used in clinical trials and patient care. (UMIN Clinical Trials Registry, Number: UMIN000041196).
Results date posted
| 2022 | Year | 07 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Altogether, 1010 patients with chronic liver disease who underwent MRI-PDFF and UGAP were recruited and prospectively enrolled from 6 Japanese liver centers. Linearity was evaluated using intraclass correlation coefficients between MRI-PDFF and UGAP values. Bias, defined as the mean difference between MRI-PDFF and UGAP values, was assessed by Bland-Altman analysis. UGAP cutoffs for pairwise MRI-PDFF-based steatosis grade were determined using area under the receiver-operating characteristic curve (AUROC) analyses.
Participant flow
Altogether, 1010 patients with chronic liver disease who underwent MRI-PDFF and UGAP were recruited and prospectively enrolled from 6 Japanese liver centers. Linearity was evaluated using intraclass correlation coefficients between MRI-PDFF and UGAP values. Bias, defined as the mean difference between MRI-PDFF and UGAP values, was assessed by Bland-Altman analysis. UGAP cutoffs for pairwise MRI-PDFF-based steatosis grade were determined using area under the receiver-operating characteristic curve (AUROC) analyses.
Adverse events
none
Outcome measures
Altogether, 1010 patients with chronic liver disease who underwent MRI-PDFF and UGAP were recruited and prospectively enrolled from 6 Japanese liver centers. Linearity was evaluated using intraclass correlation coefficients between MRI-PDFF and UGAP values. Bias, defined as the mean difference between MRI-PDFF and UGAP values, was assessed by Bland-Altman analysis. UGAP cutoffs for pairwise MRI-PDFF-based steatosis grade were determined using area under the receiver-operating characteristic curve (AUROC) analyses.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Evidence of the superiority of UGAP methods for the detection and quantification of the hepatic steatosis. Acquisition of the optimal cut-off values for the diagnosis of hepatic steatosis. Academical manuscripts and clinical presentations on the results.
Management information
Registered date
| 2020 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047037
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