UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Healthy volunteer study using a newly developed PET tracer for analysis of organic anion transporter: [18F]PTV-F1
Title of the study (Brief title)	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	Chio Okuyama
Organization	Shiga Medical Center Research Institute
Division name	Imaging Reasearch
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	Chio Okuyama
Organization	Shiga Medical Center Research Institute
Division name	head office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 19 Day
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

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Publication of results	Unpublished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