UMIN-CTR Clinical Trial

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