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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030049
Receipt No. R000034314
Scientific Title PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV
Date of disclosure of the study information 2017/11/20
Last modified on 2018/11/21

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Basic information
Public title PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV
Acronym PET study in Humans with [18F]PTV
Scientific Title PET Imaging-Based Evaluaion of Hepaobiliary transport in Humans with [18F]PTV
Scientific Title:Acronym PET study in Humans with [18F]PTV
Region
Japan

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

Objectives
Narrative objectives1 To investigate hepatic uptake and subsequent canalicular efflux of [18F]PTV in healthy subjects.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Disribution of Radioacivity in human dbdominal region and blood after adminisration of [18F]PTV
Key secondary outcomes metabolite analysis of human blood by TLC

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This study includes PET scan for 2 times.
For the first visit, the participants take only water.
Interventions/Control_2 For the second visit, they take livalo with water.
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
64 years-old >=
Gender Male
Key inclusion criteria healhy male who can have PET scan for about 90 min and temporal blood sampling for about 15 points.
Key exclusion criteria 1.those who have compligating disordes of
severe cenral nervous system, liver, and kidney damage.
2.those who take hyperlipidemia treatment, tuberculosis drug and other treatments for target regions.
3.those who are claustrophobia.
4.those who are not suiable for this study assessed by medical docors judge
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyoshi Watanabe
Organization Osaka City Universiy ;RIKEN CLST
Division name Graduate School of Medicine
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL 078-304-7101
Email yywata@riken.jp

Public contact
Name of contact person
1st name
Middle name
Last name Emi Yamano
Organization RIKEN
Division name Health Metrics Development Team
Zip code
Address 6-7-1, Minatojima-minamimachi, Chuo-ku, Kobe
TEL 078-569-8868
Homepage URL
Email emi.yamano@riken.jp

Sponsor
Institute RIKEN CLST
Institute
Department

Funding Source
Organization TAKEDA science foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Osaka City University Department of Nuclear Medicine, Osaka City University Department of Physiology, RIKEN
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 3489
Org. issuing International ID_1 Osaka City University Graduate School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪市立大学医学部附属病院 核医学科、大阪市立大学大学院医学研究科生理学第一

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 20 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
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 08 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 20 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034314

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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