UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017335
Receipt number R000010078
Scientific Title In vivo visualization of a-synuclein deposition by [11C]BF-227 PET in Parkinson's disease and Parkinsonian syndrome
Date of disclosure of the study information 2015/04/30
Last modified on 2017/12/07 13:32:19

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Basic information

Public title

In vivo visualization of a-synuclein deposition by [11C]BF-227 PET in Parkinson's disease and Parkinsonian syndrome

Acronym

In vivo visualization of a-synuclein deposition by [11C]BF-227 PET in Parkinson's disease and Parkinsonian syndrome

Scientific Title

In vivo visualization of a-synuclein deposition by [11C]BF-227 PET in Parkinson's disease and Parkinsonian syndrome

Scientific Title:Acronym

In vivo visualization of a-synuclein deposition by [11C]BF-227 PET in Parkinson's disease and Parkinsonian syndrome

Region

Japan


Condition

Condition

Parkinson's disease and parkinsonian syndrome

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The histopathological hallmark of Parkinson's disease and parkinsonian syndrome is the incidence of a-synuclein-containing Lewy bodies (LBs) and glial cytoplasmic inclusions (GCIs). However, in vivo visualization of a-synuclein depositions in the human brain remains to be impossible. We studied to demonstrate the potential of the binding of BF-227 to a-synuclein-containg LBs and GCIs.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

High uptake of BF-227 by PET image

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Duration: from September, 2012 to August, 2022
Dose: about 333MBq of [11C]BF-227

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Diagnostic criteria of Ministry of Health, Labour and Welfare

Key exclusion criteria

Patients with severe cardiac, renal, or liver diseases
Patients with pregnancy or breast-feeding

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akio Kikuchi

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Neurology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

TEL

022-717-7189

Email

akikuchi@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akio Kikuchi

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Neurology

Zip code


Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan

TEL

022-717-7189

Homepage URL


Email

akikuchi@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (C)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

東北大学病院(宮城県)


Other administrative information

Date of disclosure of the study information

2015 Year 04 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

Open public recruiting

Date of protocol fixation

2012 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2012 Year 09 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

2015 Year 04 Month 30 Day

Last modified on

2017 Year 12 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name