UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012396 |
|---|---|
| Receipt number | R000014500 |
| Scientific Title | Assessment of human radiation dose of metabotropic glutamate receptor type 1 ligand [C-11]ITMM PET/CT |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2017/05/31 10:21:05 |
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Basic information
Public title
Assessment of human radiation dose of metabotropic glutamate receptor type 1 ligand [C-11]ITMM PET/CT
Acronym
Dosimetry of [C-11]ITMM PET/CT
Scientific Title
Assessment of human radiation dose of metabotropic glutamate receptor type 1 ligand [C-11]ITMM PET/CT
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kenji Ishii |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
ishii@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ishii Kenji |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
ishii@pet.tmig.or.jp
Sponsor or person
Institute
Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014500
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
