Unique ID issued by UMIN | UMIN000047411 |
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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 |
Multicenter study for diagnosing hepatic steatosis using attenuation measurement (ATT); Comparison with PDFF (MRI-determined proton density fat fraction).
ATT (Attenuation Measurement) study
Multicenter study for diagnosing hepatic steatosis using attenuation measurement (ATT); Comparison with PDFF (MRI-determined proton density fat fraction).
ATT (Attenuation Measurement) study
Japan |
Chronic liver disease
Hepato-biliary-pancreatic medicine | Radiology |
Others
NO
Evaluation of hepatic steatosis by ATT
Efficacy
We assess the accuracy of ATT in assessing hepatic steatosis compared to PDFF
We verify whether ATT can diagnose fatty liver (liver fat content 5% or more)
Observational
18 | years-old | <= |
90 | years-old | >= |
Male and Female
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.
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.
750
1st name | Hidenori |
Middle name | |
Last name | Toyoda |
Ogaki Municipal Hospital
Department of Gastroenterology and Hepatology
503-8502
4-86 Minaminokawa-cho, Ogaki-shi, Gifu-ken
+81584813341
hmtoyoda@spice.ocn.ne.jp
1st name | Takashi |
Middle name | |
Last name | Kumada |
Gifu Kyoritsu University
Department of Nursing, Faculty of Nursing
503-8550
5-50, Kitagata-cho, Ogaki-shi, Gifu-ken
+81584773512
takashi.kumada@gmail.com
Ogaki Municipal Hospital
FUJIFILM Healthcare Corporation
Profit organization
Japan
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
None
Ogaki Municipal Hospital
4-86/Minaminokawa, Ogaki, Gifu, Japan, 503-8502
+81-584-81-3341
clinical-trial@omh.ogaki.gifu.jp
NO
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
2022 | Year | 04 | Month | 18 | Day |
https://pubmed.ncbi.nlm.nih.gov/38553657/
Partially published
https://pubmed.ncbi.nlm.nih.gov/38553657/
846
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.
2024 | Year | 04 | Month | 08 | Day |
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.
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.
None
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).
No longer recruiting
2021 | Year | 04 | Month | 08 | Day |
2021 | Year | 04 | Month | 23 | Day |
2021 | Year | 05 | Month | 27 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
None
2022 | Year | 04 | Month | 06 | Day |
2024 | Year | 04 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054070
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