UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of human radiation dose of metabotropic glutamate receptor type 1 ligand [C-11]ITMM PET/CT
Title of the study (Brief title)	Dosimetry of [C-11]ITMM PET/CT
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of [C-11]ITMM PET/CT dosimetry in healthy volunteers.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Pharmacokinetics, Dosimetry
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	Prevention
Type of intervention	Medicine
Interventions/Control_1	The dosage in the vein of [C-11]ITMM for PET/CT imaging.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. The subjects who has intention to participate in this study, and signed informed consent. 2. Male and female subjects of >=20 and <60 years, old. 3. The subject who was judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.
Key exclusion criteria	1.The subject who has dysfunction in the liver / kidney. 2.The subject who has abnormal findings in the central nervous system. 3.The subjects having cardiac failure. 4.The subject with a history of a drug or food allergy. 5.Tobacco smoker
Target sample size	12

Research contact person
Name of lead principal investigator	Kenji Ishii
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Email	ishii@pet.tmig.or.jp

Public contact
Name of contact person	Ishii Kenji
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Address	35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Homepage URL
Email	ishii@pet.tmig.or.jp

Sponsor
Institute	Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
Institute
Department

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

Other related organizations
Co-sponsor
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	地方独立行政法人東京都健康長寿医療センター研究所

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 25 Day
Last follow-up date	2014 Year 05 Month 16 Day
Date of closure to data entry	2014 Year 05 Month 16 Day
Date trial data considered complete	2014 Year 06 Month 30 Day
Date analysis concluded	2014 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 25 Day
Last modified on	2017 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014500