UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015453
Receipt No. 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 2017/08/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
Email

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
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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 07 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
2014 Year 10 Month 17 Day
Last modified on
2017 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.