UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047411 |
|---|---|
| Receipt number | R000054070 |
| Scientific Title | Multicenter study for diagnosing hepatic steatosis using attenuation measurement (ATT); Comparison with PDFF (MRI-determined proton density fat fraction). |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2024/04/08 09:42:56 |
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Basic information
Public title
Multicenter study for diagnosing hepatic steatosis using attenuation measurement (ATT); Comparison with PDFF (MRI-determined proton density fat fraction).
Acronym
ATT (Attenuation Measurement) study
Scientific Title
Multicenter study for diagnosing hepatic steatosis using attenuation measurement (ATT); Comparison with PDFF (MRI-determined proton density fat fraction).
Scientific Title:Acronym
ATT (Attenuation Measurement) 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 ATT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the accuracy of ATT in assessing hepatic steatosis compared to PDFF
Key secondary outcomes
We verify whether ATT 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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ATT and PDFF within 3 months
Patients with chronic liver disease including viral hepatitis, NAFLD, autoimmune hepatitis, primary biliary cholangitis, and so on
Patients who can follow instructions such as breath-holding.
Key exclusion criteria
Patients without claustrophobia
Patients without magnetic substance or tattoo
Patients without pacemakers
Patients judged as inappropriate for the study by the study responsibility (share) physician.
Target sample size
750
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
503-8502
Address
4-86 Minaminokawa-cho, Ogaki-shi, Gifu-ken
TEL
+81584813341
hmtoyoda@spice.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kumada |
Organization
Gifu Kyoritsu University
Division name
Department of Nursing, Faculty of Nursing
Zip code
503-8550
Address
5-50, Kitagata-cho, Ogaki-shi, Gifu-ken
TEL
+81584773512
Homepage URL
takashi.kumada@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Healthcare Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Gastroenterology and Metabology, Ehime University School of Medicine.
Department of Gastroenterology, Suita Municipal hospital
Department of Nursing, Gifu Kyoritsu University
Department of Hepatology and Pancreatology, Aichi Medical University
Department of Advanced Metabolic Hepatology, Osaka University Graduate School of Medicine
Department of Gastroenterology, Kagoshima City Hospital
Department of Medical Division of Gastroenterology, Kurume University
Clinical Research Center, National Hospital Organization Nagasaki Medical Center
Department of Gastroenterology, Sasebo City General Hospital
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
大垣市民病院消化器内科) Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital
愛媛大学大学院医学系研究科医学専攻消化器・内分泌・代謝内科学 Department of Gastroenterology and Metabology, Ehime University School of Medicine.
市立吹田市民病院 消化器内科 Department of Gastroenterology, Suita Municipal hospital
鹿児島市立病院 消化器内科 Department of Gastroenterology, Kagoshima City Hospital
久留米大学医学部内科学講座 消化器内科部門 Department of Medical Division of Gastroenterology, Kurume University
国立病院機構長崎医療センター 臨床研究センター/肝臓内科 Clinical Research Center, National Hospital Organization Nagasaki Medical Center
佐世保市総合医療センター 消化器内科 Department of Gastroenterology, Sasebo City General Hospital
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/38553657/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38553657/
Number of participants that the trial has enrolled
846
Results
Bland-Altman analysis showed minimal fixed bias between iATT and MRI-PDFF with excellent reproducibility. The area under the curve to distinguish lipodystrophy grades 1, 2, and 3 was 0.887, 0.882, and 0.867, respectively. Skin to capsular distance greater than 25 mm was identified as the only significant factor causing discordance. no interaction between MRI-logPDFF and MRE-LSM on iATT values was observed.
Results date posted
| 2024 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Several preliminary reports have suggested the utility of ultrasound attenuation coefficient measurements based on B-mode ultrasound, such as iATT, for diagnosing steatotic liver disease. Nonetheless, evidence supporting such utility is lacking. This prospective study aimed to investigate whether iATT is highly concordant with magnetic resonance imaging (MRI)-based proton density fat fraction (MRI-PDFF) and could well distinguish between steatosis grades.
Participant flow
A cohort of 846 individuals underwent both iATT and MRI-PDFF assessments. Steatosis grade was defined as grade 0 with MRI-PDFF < 5.2%, grade 1 with 5.2% MRI-PDFF < 11.3%, grade 2 with 11.3% MRI-PDFF < 17.1%, and grade 3 with MRI-PDFF of 17.1%. The reproducibility of iATT and MRI-PDFF was evaluated using the Bland-Altman analysis and intraclass correlation coefficients, whereas the diagnostic performance of each steatosis grade was examined using receiver operating characteristic analysis.
Adverse events
None
Outcome measures
Compared to MRI-PDFF, iATT showed excellent diagnostic accuracy in grading steatosis. iATT could be used as a diagnostic tool instead of MRI in clinical practice and trials. Trial registration This study was registered in the UMIN Clinical Trials Registry (UMIN000047411).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054070
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