UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013339 |
|---|---|
| Receipt number | R000015570 |
| Scientific Title | Scanning optimization and evaluation of aging effect of dopamine transporter ligand [C-11]PE2I |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2024/03/12 12:53:29 |
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Basic information
Public title
Scanning optimization and evaluation of aging effect of dopamine transporter ligand [C-11]PE2I
Acronym
Scanning optimization and aging effect of DAT PET with [C-11]PE2I
Scientific Title
Scanning optimization and evaluation of aging effect of dopamine transporter ligand [C-11]PE2I
Scientific Title:Acronym
Scanning optimization and aging effect of DAT PET with [C-11]PE2I
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Scanning optimization and aging effect of DAT PET with [C-11]PE2I
Basic objectives2
Others
Basic objectives -Others
Investigation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binding potential and tissue concentration ratio
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]PE2I 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
| 80 | 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 =<80 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
6.Pregnant or woman who has a chance of pregnant.
7.The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Neuroimaging
Zip code
1730015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
+81-3-3964-3241
ishii@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Ishii |
Organization
Tokyo Metropolitan Institute of Geriatrics and Gerontology
Division name
Research Team for Neuroimaging
Zip code
1730015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
+81-3-3964-3241
Homepage URL
ishii@pet.tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Kenji Ishii
Funding Source
Organization
Research Team for Neuroimaging, Tokyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee, Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakaecho, Itabashi-ku, Tokyo 173-0015, Japan
Tel
0339643241
rinsyoshiken@tmghig.jp
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
東京都健康長寿医療センター研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
11
Results
Dopamine transporter PET study using 11C-PE2I (PE2I) and 11C-CFT (CFT) were conducted on 11 normal male and female volunteers aged 22 to 79 years, and head-to-head comparative analysis was performed. A very good correlation was observed between PE2I and CFT SUVR values (R2=9.122).
When measuring the volume of areas with PE2I SUVR of 5 or higher, age-related changes (5-7%/10 years) were observed.
Results date posted
| 2024 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Inclusion criteria
(1) Healthy Japanese applicants, regardless of gender.
(2) Persons who are 20 years of age or older at the time of obtaining consent
(3) UPDRS Part III total score is 0 (60 years old or younger) or less than 5 (61 years old or older)
(4) Beck Depression Inventory less than 10 points
(5) MMES 28 points or more
(6) Persons with no brain abnormalities detected by regular MRI or computed tomography (hereinafter referred to as CT). However, age-appropriate ventricular enlargement, atrophy, normal mutations, and so-called "white matter lesions" seen in middle-aged and elderly people may be present.
(7) Persons who have the ability to understand and comply with the contents of this research.
(8) A person whose written consent can be obtained from the person concerned.
2. Exclusion criteria
(1) Persons diagnosed with dementia according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th revised edition (DSM-IV-TR)
(2) Persons for whom MRI examination is absolutely contraindicated (persons with cardiac pacemakers, persons with cochlear implants)
(3) Persons using drugs containing the following drugs that are thought to affect the accumulation of this drug in the brain:
Cocaine hydrochloride, mazindol, methylphenidate hydrochloride, sertraline hydrochloride, selective serotonin reuptake inhibitors
(4) Persons with severe allergies to drugs such as alcohol and iodine
(5) Pregnant women, lactating women, and those who may be pregnant.
(6) A person who is judged to be inappropriate by the clinical trial investigator, etc. when conducting this trial.
Participant flow
The 11 subjects who met the above inclusion and exclusion criteria provided written informed consent and underwent PET examination.
Adverse events
No adverse events were observed.
Outcome measures
1. Ratio of the uptake value in the subregions of the left and right striatum (caudate nucleus, anterior putamen, posterior putamen) and the uptake value in the reference region (cerebellar cortex) (SUVR).
2. Volume of striatal region
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015570
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| Registered date | File name |
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