UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017763
Receipt number R000020572
Scientific Title Comparison of striatal accumulation of dopamine transporter ligands with PET and SPECT
Date of disclosure of the study information 2015/06/01
Last modified on 2021/09/08 11:20:27

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Basic information

Public title

Comparison of striatal accumulation of dopamine transporter ligands with PET and SPECT

Acronym

Comparison of PET and SPECT dopamine transporter imaging

Scientific Title

Comparison of striatal accumulation of dopamine transporter ligands with PET and SPECT

Scientific Title:Acronym

Comparison of PET and SPECT dopamine transporter imaging

Region

Japan


Condition

Condition

Parkinson syndrome and healthy volunteer

Classification by specialty

Neurology Radiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigating the bindings of 123I-ioflupane and 11C-PE2I in the striatum

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between the bindings of 123I-ioflupane and 11C-PE2I in the striatum in healthy control and Parkinson syndrome

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

1. The subjects who have intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=20 years, old.
3. The subjects who were diagnosed with Parkinson syndrome or healthy adult

Key exclusion criteria

1. The subjects with a history of brain diseases, excluding than cerebellar diseases.
2. The subjects who are prescribed a medication for the central nervous system.
3. The subject who have chronic dysfunction in the organs.
4. Pregnant or woman who has a chance of pregnant.
5. The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.

Target sample size

40


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

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

TEL

03-3964-3241

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

03-3964-3241

Homepage URL


Email

ishii@pet.tmig.or.jp


Sponsor or person

Institute

Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

Institute

Department

Personal name



Funding Source

Organization

Nihon Medi-Physics Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Review Board, Tokyo Metropolitan Geriatric Center

Address

35-2 Sakaecho, Itabashi-ku, Tokyo

Tel

03-3964-3241

Email

chiken@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

地方独立行政法人東京都健康長寿医療センター研究所


Other administrative information

Date of disclosure of the study information

2015 Year 06 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

2015 Year 04 Month 10 Day

Date of IRB

2015 Year 03 Month 30 Day

Anticipated trial start date

2015 Year 06 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 06 Month 30 Day

Date trial data considered complete

2019 Year 09 Month 30 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

We studied 12 cases of Parkinson's disease or related disorders with [123I]FP-CIT SPECT and [11C]CFT/[11C]PI2I PET. A head-to-head comparison of regional uptake of the tracers in the subregions of striatum appeared to be well correlated (R2 > 0.88). Quantitative evaluation of striatal pre-synaptic dopaminergic function with [123I]FP-CIT SPECT is considered to be a reliable method.


Management information

Registered date

2015 Year 06 Month 01 Day

Last modified on

2021 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name