UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014709
Receipt number R000017098
Scientific Title Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I
Date of disclosure of the study information 2014/08/01
Last modified on 2020/08/03 14:07:20

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Basic information

Public title

Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I

Acronym

DAT PET with [C-11]PE2I in PD and related disorders

Scientific Title

Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I

Scientific Title:Acronym

DAT PET with [C-11]PE2I in PD and related disorders

Region

Japan


Condition

Condition

Patients of Parkinson's disease and related disorders

Classification by specialty

Neurology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Detection of nigral degeneration in Parkinson's disease and related disorders with DAT PET with [C-11]PE2I

Basic objectives2

Others

Basic objectives -Others

Investigation

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Binding potential and tissue concentration ratio

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

Prevention

Type of intervention

Medicine

Interventions/Control_1

The dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. The subjects who has intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=18 years old.
3. The subject who was judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.

Key exclusion criteria

1.The subject who has dysfunction in the liver / kidney.
2.The subject who has abnormal findings in the central nervous system other than the target disorders.
3.The subjects having cardiac failure.
4.The subject with a history of a drug or food allergy.
5.Pregnant or woman who has a chance of pregnant.
6.The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Ishii

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Neuroimaging

Zip code

1730015

Address

Itabashi-ku

TEL

0339643241

Email

ishii@pet.tmig.or.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Ishii

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Neuroimaging

Zip code

1730015

Address

35-2, Sakae-cho, Itabashi-ku, Tokyo

TEL

0339643241

Homepage URL


Email

ishii@pet.tmig.or.jp


Sponsor or person

Institute

Tokyo Metropolitan Institute of Gerontology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee, Tokyo Metropolitan Institute of Gerontology

Address

35-2 Sakaecho, Itabashi-ku, Tokyo 1730015, Japan

Tel

0339643241

Email

naomi_hasegawa@tmghig.jp


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

東京都健康長寿医療センター研究所(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 01 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

Completed

Date of protocol fixation

2014 Year 06 Month 12 Day

Date of IRB

2014 Year 06 Month 12 Day

Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2019 Year 09 Month 30 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 07 Month 30 Day

Last modified on

2020 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017098


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name