UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048672 |
|---|---|
| Receipt number | R000051728 |
| Scientific Title | The diagnostic ability for hepatic steatosis using ultrasound attenuation imaging as reference standerd MRI-PDFF, liver tissue and controlled attenuation parameter(CAP); a prospective multicenter study. |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2025/02/17 08:13:38 |
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Basic information
Public title
The diagnostic ability for hepatic steatosis using ultrasound attenuation imaging as reference standerd MRI-PDFF, liver tissue and controlled attenuation parameter(CAP); a prospective multicenter study.
Acronym
The diagnostic ability for hepatic steatosis using ultrasound attenuation imaging as reference standerd MRI-PDFF, liver tissue and controlled attenuation parameter(CAP); a prospective multicenter study.
Scientific Title
The diagnostic ability for hepatic steatosis using ultrasound attenuation imaging as reference standerd MRI-PDFF, liver tissue and controlled attenuation parameter(CAP); a prospective multicenter study.
Scientific Title:Acronym
The diagnostic ability for hepatic steatosis using ultrasound attenuation imaging as reference standerd MRI-PDFF, liver tissue and controlled attenuation parameter(CAP); a prospective multicenter study.
Region
| Japan |
Condition
Condition
chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The diagnostic ability for the hepatic steatosis using ultrasound attenuation imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic ability for the hepatic steatosis using ultrasound attenuation imaging
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic liver disease
Patients who underwent ATI and MRI-PDFF or CAP or liver biopsy within 1 month
Patients who can follow instructions such as breath-holding
Key exclusion criteria
In patients who underwent MRI-PDFF,
patients with claustrophobia
patients with magnetic substance or
tattoo
patients with pacemakers
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 | Hiroko |
| Middle name | |
| Last name | Iijima |
Organization
Hyogo Medical University
Division name
Department of Internal medicine, Division of Gastroenterology and hepatology/Ultrasound Imaging Center
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo prefecture
TEL
0798-45-6472
hiroko-i@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Nihsimura |
Organization
Hyogo Medical University
Division name
Department of Internal medicine,Division of Gastroenterology/Ultrasound Imaging Center
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo prefecture
TEL
0798-45-6472
Homepage URL
tk-nishimura@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Select a State or Province
Other related organizations
Co-sponsor
Department of Gastroenterology and HepatologyOgaki Municipal Hospital,
Department of Internal Medicine, Japanese Red Cross Himeji Hospital,
Department of Gastroenterology, Nayoro City General Hospital,
Division of Hepatology, Department of Internal Medicine, Iwate Medical University,
Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine,
Department of Gastroenterology, Shin-yurigaoka General Hospital,
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine,
Liver Center, Saga University Hospital, Faculty of Medicine, Saga University,
Department of Pathology, Kurume University School of Medicine,
Department of Epidemiology, Infectious Disease Control, and Prevention, Hiroshima University Institute of Biomedical and Health Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1, Mukogawa-cho,Nishinomiya-city, Hyogo prefecture
Tel
0798456111
rinri@hyo-med.ac.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
兵庫医科大学 消化器内科学/超音波センター（兵庫県）
大垣市民病院 消化器内科（岐阜県）
姫路赤十字病院 内科（兵庫県）
名寄市立総合病院 消化器内科（北海道）
岩手医科大学 内科学講座消化器内科肝臓分野（岩手県）
東京医科大学 消化器内科（東京都）
横浜市立大学 大学院医学研究科肝胆膵消化器病学（神奈川県）
新百合ヶ丘総合病院 消化器内科（神奈川県）
愛媛大学 大学院消化器・内分泌・代謝内科学（愛媛県）
佐賀大学医学部附属病院 肝疾患センター（佐賀県）
久留米大学医学部病理学講座（福岡県）
広島大学 大学院医系科学研究科疫学・疾病制御学（広島県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2022 | Year | 08 | Month | 16 | 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=R000051728
