UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015453 |
|---|---|
| Receipt number | R000017969 |
| Scientific Title | A multicenter comparison study between [11C]PBB3 PET and histopathology |
| Date of disclosure of the study information | 2014/10/17 |
| Last modified on | 2021/10/21 17:20:59 |
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Basic information
Public title
A multicenter comparison study between [11C]PBB3 PET and histopathology
Acronym
PBB3 4th protocol(Multicenter)
Scientific Title
A multicenter comparison study between [11C]PBB3 PET and histopathology
Scientific Title:Acronym
PBB3 4th protocol(Multicenter)
Region
| Japan |
Condition
Condition
Healthy volunteers 20 years of age or older at the time of obtaining consent
Patients with probably tau-mediated neuropsychiatric disorders 20 years of age or older at the time of obtaining consent
Patients with ante-mortem conscent for autopsy 20 years of age or older at the time of obtaining consent
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between [11C]PBB3 binding and clinical manifestations, and the compatibility between [11C]PBB3 PET and histopathological findings.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between [11C]PBB3 binding and clinical manifestations, and the compatibility between [11C]PBB3 PET and histopathological findings.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution volume SUV, and SUVR measured by positron emission tomography with [11C]PBB3
Key secondary outcomes
Comparison among [11C]PBB3 PET, amyloid PET and clinical manifestations
Comparison between [11C]PBB3 PET and histopathological findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/psychological batteries/neurological examinations
Interventions/Control_2
PET/MRI/psychological batteries/neurological examinations
Interventions/Control_3
PET/MRI/psychological batteries/neurological examinations
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
1. 20 years of age or older at the time of obtaining consent. For the judgment of whether or not subject cognitive function can be deemed normal.
2. In order to reduce gender bias, subjects will be selected to match the male-to-female ratios of the patient groups to the maximum extent possible.
3. Healthy subjects who have the ability to consent to participate in this study, to read and understand the informed consent form.
Patients with probably tau-mediated neuropsychiatric disorders
Patients with ante-mortem consent for autopsy
1.Patients 20 years of age or older at the time of obtaining consent.
2.Details of inclusion criteria are determined separately in each center.
Key exclusion criteria
healthy volunteer
1. Subjects with organic brain complications/disorders (including a history of symptomatic cerebral infarction, Parkinson's disease and similar conditions).
2. Patients with substance-related disorders (including drug abuse). For the acceptable range of allowable drugs.
3. Subjects with severe physical complications/disorders or a history of such conditions and who are considered to be inappropriate for participation by the aforementioned doctors with responsibilities in this study.
4. Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.).
5. Subjects with tattoos. Subjects with claustrophobia.
6. Pregnant, possibly pregnant or lactating women.
7. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study.
8. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study.
Patients with probably tau-mediated neuropsychiatric disorders
Patients with ante-mortem consent for autopsy
Details of exclusion criteria are determined separately in each center.
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya SUHARA |
Organization
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
suhara.tetsuya@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko SUZUKI |
Organization
National Institute of Radiological Sciences
Division name
Clinical Research Support Section
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
a consignment expense for Molecular Imaging
Program on "Research Base for PET
diagnosis" from the Ministry of Education,
Culture, Sports, Science and Technology
(MEXT), Japanese Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan Geriatric Hospital
National Center of Neurology and Psychiatry
Mihara Memorial Hospital
Fukushimura Hospital
Nippon Medical School
Hamamatsu University School of Medicine
Osaka City University
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
| 2014 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
480
Results
[11C]PBB3 PET showed that tau pathology was observed in the area of high ligand accumulation. The results of this study were presented at national and international conferences, and a paper is in preparation.
Results date posted
| 2021 | Year | 10 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
No adverse events were observed.
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 25 | 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 | 10 | Month | 17 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017969
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
