UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010305
Receipt No. R000012061
Scientific Title Healthy volunteer study using a newly developed PET tracer for analysis of organic anion transporter: [18F]PTV-F1
Date of disclosure of the study information 2013/03/22
Last modified on 2019/02/01

* 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 Healthy volunteer study using a newly developed PET tracer for analysis of organic anion transporter: [18F]PTV-F1
Acronym Healthy volunteer study using a newly developed PET tracer : [18F]PTV-F1
Scientific Title Healthy volunteer study using a newly developed PET tracer for analysis of organic anion transporter: [18F]PTV-F1
Scientific Title:Acronym Healthy volunteer study using a newly developed PET tracer : [18F]PTV-F1
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Semiquantitative analysis of organic anion transporting polypeptide using [18F]PTV-F1 PET
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Semiquantitative analysis of organic anion transporting polypeptide using [18F]PTV-F1 PET
Key secondary outcomes

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 Diagnosis
Type of intervention
Medicine
Interventions/Control_1 injection of PET tracer
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
70 years-old >
Gender Male and Female
Key inclusion criteria healthy volunteers
Key exclusion criteria patients with liver diseases
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chio Okuyama
Organization Shiga Medical Center Research Institute
Division name Imaging Reasearch
Zip code
Address 5-4-40 Moriyama, Moriyama-City, Shiga
TEL 077-582-6034
Email okuyama@res.med.shiga-pref.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chio Okuyama
Organization Shiga Medical Center Research Institute
Division name head office
Zip code
Address 5-4-40 Moriyama, Moriyama-City, Shiga
TEL 077-582-6034
Homepage URL http://www.shigamed.jp/
Email okuyama@res.med.shiga-pref.jp

Sponsor
Institute Shiga Medical Center Research Institute
Institute
Department

Funding Source
Organization Shiga Medical Center Research Institute
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Patho-Functional Bioanalysis
Graduate School of Pharmaceutical Sciences, KYOTO UNIVERSITY
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 滋賀県立総合病院研究所

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 22 Day

Related information
URL releasing protocol http://www.shigamed.jp/
Publication of results Unpublished

Result
URL related to results and publications http://www.shigamed.jp/
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 Completed
Date of protocol fixation
2013 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 21 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 22 Day
Last modified on
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.