UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Brain Dopaminergic Function using 18F-FDOPA PET in Parkinson's Disease and Related Disorders
Title of the study (Brief title)	18F-FDOPA PET in Parkinson's Disease and Related Disorders
Region	Japan

Condition
Condition	Parkinson's disease and related disorders
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness of 18F-FDOPA PET in the differential diagnosis of Parkinson's disease from other related disorders.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	18F-FDOPA PET imaging
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with Parkinson's disease based on the UK Brain Bank criteria 2. Patients with Parkinson's disease related disorders which are difficult to differentiate them from Parkinson's disease 3. Patients whose dopaminergic therapy can be stopped before PET if they have already started dopamine replacement therapy
Key exclusion criteria	1. Patients who cannot stay rest on a scanner bed at least for 60 minutes
Target sample size	50

Research contact person
Name of lead principal investigator	Hidenao Fukuyama
Organization	Kyoto University Graduate School of Medicine
Division name	Human Brain Research Center
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3695
Email	fukuyama@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Naoya Oishi
Organization	Kyoto University Graduate School of Medicine
Division name	Human Brain Research Center
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3695
Homepage URL
Email	noishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Human Brain Research Center, Kyoto University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Takeda Science Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 06 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 04 Month 17 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	PET scanning using 18F-FDOPA takes place. Neurological examinations takes place within a month before, 6 and 12 months after PET.

Management information
Registered date	2012 Year 04 Month 17 Day
Last modified on	2016 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009160