UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033058
Receipt No. R000034344
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)
Date of disclosure of the study information 2018/06/25
Last modified on 2018/06/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Kohei Kotani, M.D., Ph.D.
Organization Osaka City University Graduate School of Medicine
Division name Hepatology
Zip code
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
Middle name
Last name Kohei Kotani, M.D., Ph.D.
Organization Osaka City University Graduate School of Medicine
Division name Hepatology
Zip code
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
Address
Tel
Email

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
2018 Year 06 Month 19 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.