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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037051
Receipt No. R000042221
Scientific Title Innovative Liver Elasticity, Attenuation, and Dispersion ultrasound study
Date of disclosure of the study information 2019/06/15
Last modified on 2019/06/13

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Basic information
Public title Innovative Liver Elasticity, Attenuation, and Dispersion ultrasound study
Acronym Innovative Liver Elasticity, Attenuation, and Dispersion ultrasound study
Scientific Title Innovative Liver Elasticity, Attenuation, and Dispersion ultrasound study
Scientific Title:Acronym iLEAD
Region
Japan North America Europe

Condition
Condition NASH
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is:(1)Investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and fat); under the study hypothesis that significant correlations exist for SW speed with liver fibrosis, Dispersion slope with intralobular inflammation, and Attenuation value with steatosis (2) evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the gold standard: tissue diagnosis by liver biopsy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate the diagnostic performance of Dispersion slope for intralobular inflammation (A01 vs. A23).
Key secondary outcomes (a) The correlation between ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, and Liver/Kidney Intensity Ratio) and the pathological parameters (liver fibrosis, intralobular inflammation, ballooning and steatosis).
(b) Diagnostic performance of SW speed for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
(c) Diagnostic performance of Normalized Local Variance for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).
(d) Diagnostic performance of Normalized Local Variance for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
(e) Diagnostic performance of Dispersion slope for intralobular inflammation (A0 vs. A123, and A012 vs. A3).
(f) Diagnostic performance of Attenuation value for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
(g) Diagnostic performance of Liver/Kidney Intensity Ratio for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
(h) Diagnostic performance of the computer aided algorithm for NASH
(i) Diagnostic performance of MRI-PDFF for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
(j) Diagnostic performance of CAP for steatosis (S0 vs. S123, S01 vs. S23, and S012 vs. S3).
(k) Diagnostic performance of MRE for fibrosis (F0 vs. F1234, F01 vs. F234, F012 vs. F34, and F0123 vs. F4).

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Male or female aged 20 or older.
2. Scheduled cases for liver biopsy for the (differential) diagnosis of NASH. (for the institutes where biopsy is not available, the scheduled cases for the MRE and MRI-PDFF examination)
3. Without a history of alcohol use, which lead to alcoholic hepatic involvement. (pure alcohol below 30g/day for male, 20g/day for female)
Key exclusion criteria 1. Patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the Steatosis.
2. Hepatitis B, Hepatitis C and HIV patients (Even NAFLD complicated with such clinical condition should be excluded)
3. Primary biliary cholangitis, Primary sclerosing cholangitis, and Autoimmune hepatitis patients
4. Wilson's disease, a1-antitrypsin deficiency, and Hemochromatosis patients.
5. Malignant liver tumor, common bile duct stone, and jaundice patients
6. Patients after jejunoileal bypass surgery or massive intestinal resection surgery.
7. Patients whose treatment changes during the period betweenimage examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver. However,patients that have taken medicications before this period may be considered for enrollment.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Fuminori
Middle name
Last name Moriyasu
Organization International University of Health and Welfare
Sanno Hospital
Division name Dept. of Gastroenterology and Hepatology
Zip code 107-0052
Address 8-10-16 Akasaka, Minato-ku, Tokyo
TEL 03-3402-3151
Email moriyasu@iuhw.ac.jp

Public contact
Name of contact person
1st name Katsutoshi
Middle name
Last name Sugimoto
Organization Tokyo Medical University
Division name Dept. of Gastroenterology and Hepatology
Zip code 160-0023
Address 6-7-1 Nishishinjuku Shinjuku-ku
TEL 03-32-6111
Homepage URL
Email sugimoto@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization Tokyo Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyogo Medical College
Kurume University
Name of secondary funder(s) Canon Medical systems co.

IRB Contact (For public release)
Organization International University of Health and Welfare Sanno Hospital
Address 8-10-16 Akasaka, Minato-ku, Tokyo
Tel 03-3402-3151
Email moriyasu@iuhw.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 11 Month 10 Day
Anticipated trial start date
2019 Year 06 Month 15 Day
Last follow-up date
2022 Year 06 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing special

Management information
Registered date
2019 Year 06 Month 13 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042221

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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