UMIN-CTR Clinical Trial

Basic information
Public title	A prospective exploratory study on the usefulness of Asialoglycoprotein Receptor Imaging in patients with Acute liver damage early in onset in Osaka City University (ARIA-OCU)
Acronym	Asialoglycoprotein Receptor Imaging in patients with Acute liver damage in Osaka City University (ARIA-OCU)
Scientific Title	A prospective exploratory study on the usefulness of Asialoglycoprotein Receptor Imaging in patients with Acute liver damage early in onset in Osaka City University (ARIA-OCU)
Scientific Title:Acronym	Asialoglycoprotein Receptor Imaging in patients with Acute liver damage in Osaka City University (ARIA-OCU)
Region	Japan

Condition
Condition	Acute liver damage
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform asialoglycoprotein receptor imaging using Tc-99m-galactosyl human serum albumin (GSA) within 3 weeks from onset and 1-2 months after onset in patients with acute liver damage who don't have a history of liver damage. Then we evaluate the significance by describing how the results of scintigraphy affect the decision and change of treatment policy, and we explore prospectively relations between scintigraphic results and severity and prognosis of acute liver damage.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of patients in whom chief physician judge 2nd asialoglycoprotein receptor imaging to be meaningful.
Key secondary outcomes	1. Comparison of treatment policies before and after asialoglycoprotein receptor imaging, and a rate of treatment policy change. 2. Percentage of patients falling into acute liver failure. 3. Correlation between the duration until falling into acute liver failure and quantitative value of asialoglycoprotein receptor imaging and its rate of change. 4. Correlation between the duration of liver damage status and quantitative value of asialoglycoprotein receptor imaging and its rate of change. 5. Percentage of patients who develop hepatic coma above II degree. 6. Correlation between the duration until developing hepatic coma above II degree and quantitative value of asialoglycoprotein receptor imaging and its rate of change. 7. Percentage of patients who died from acute liver failure. 8. Correlation between the duration until death due to acute liver failure and quantitative value of asialoglycoprotein receptor imaging and its rate of change.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	We perform asialoglycoprotein receptor imaging in patients with acute liver damage within 3 weeks and 1 to 2 months after the onset of acute liver damage. The dose of Tc-99m-GSA used for each asialoglycoprotein receptor imaging is 185 MBq. We calculate quantitative value of asialoglycoprotein receptor imaging at each time point and evaluate functional hepatic reserve. Then we investigate a significance by describing how the results of scintigraphy affect the decision and change of treatment policy.
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. Over 20 years old. 2. Asialoglycoprotein receptor imaging can be performed within 3 weeks from the onset of acute liver damage. The definition of acute liver damage is "patients showing alanine transferase values of 100 IU/L or more or total bilirubin values of 3.0 mg/dL or more due to acute liver damage, where the liver function prior to the current onset of liver damage is estimated to have been normal based on laboratory tests and imaging tests.
Key exclusion criteria	1. Severe psychiatric disorder or psychiatric symptom is merged. (provided, however, judged by the attending physician.) 2. Asialoglycoprotein receptor imaging can not be performed due to poor general condition. 3. Long-term resting supine position is difficult due to back pain. 4. Pregnant or lactating woman. 5. In a case that the researchers judge it is difficult to carry out the study.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Kohei Middle name Last name Kotani
Organization	Osaka City University Graduate School of Medicine
Division name	Hepatology
Zip code	545-8585
Address	1-4-3 Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3905
Email	kouhei-k@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Kohei Middle name Last name Kotani
Organization	Osaka City University Graduate School of Medicine
Division name	Hepatology
Zip code	45-8585
Address	1-4-3 Asahimachi, Abeno-ku, Osaka
TEL	06-6645-3905
Homepage URL
Email	kouhei-k@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science (KAKENHI)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka city university hospital echics committee
Address	1-2-7-601 Asahimachi, Abeno-ku, Osaka, Japan
Tel	06-6645-3456
Email	ethics@med.osaka-cu.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	2018 Year 06 Month 25 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 01 Month 31 Day
Date of IRB
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 06 Month 19 Day
Last modified on	2020 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034344