UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007163 |
|---|---|
| Receipt number | R000008436 |
| Scientific Title | Determination of the effect of age and gender on the norepinephrine transporter availability by using positron emission tomography with [F-18]FMeNER-D2 |
| Date of disclosure of the study information | 2012/01/30 |
| Last modified on | 2012/01/30 13:47:02 |
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Basic information
Public title
Determination of the effect of age and gender on the norepinephrine transporter availability by using positron emission tomography with [F-18]FMeNER-D2
Acronym
The effect of age and gender on the norepinephrine transporter availability
Scientific Title
Determination of the effect of age and gender on the norepinephrine transporter availability by using positron emission tomography with [F-18]FMeNER-D2
Scientific Title:Acronym
The effect of age and gender on the norepinephrine transporter availability
Region
| Japan |
Condition
Condition
Normal volunteers
Classification by specialty
| Psychiatry | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to study the effect of aging and gender on the norepinephrine transporter availability in the brain by using positron emission tomography with [F-18]FMeNER-D2.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of age and gender on the norepinephrine transporter availability
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
Intravenous injection of [F-18]FMeNER-D2
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
No current or history of psychiatric disorders and absence of severe somatic diseases.
Ability to understand an explanation document and give consent.
Key exclusion criteria
Presence of severe diseases and currently undergoing treatment for them.
Pregnant or possibility of pregnancy.
Currently breastfeeding.
Participation in the other studies involving the use of nuclear medicine within 6 months.
Judged inappropriate as a subject by the investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Suhara |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
A study ethic plan support room
Zip code
Address
TEL
Homepage URL
helsinki@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2012 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008436
