UMIN-CTR Clinical Trial

Basic information
Public title	Pathophysiological analysis of Parkinson disease and related disorders using DAT scan and MRI
Acronym	Morphological and functional imaging assessment of Parkinson disease
Scientific Title	Pathophysiological analysis of Parkinson disease and related disorders using DAT scan and MRI
Scientific Title:Acronym	Morphological and functional imaging assessment of Parkinson disease
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this work is to solve the pathophysiology of a Parkinson disease and related disorders by using multimodal neuroimaging including DAT scan and magnetic resonance imaging.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	activity of striatal dopamine transporters in Parkinson disease
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	30 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy control Patients with Parkinson disease and related disorders
Key exclusion criteria	1. Patients who are severe hepatic dysfunction 2. Patients who are severe renal dysfunction or dialysis ESRD 3. Patients who are past history of hypersensitivity to Alcohol 4. Patients who are taking medicine which affects the uptake of [123I]-Ioflupane 5. Patients who have voiding dysfunction 6. Pregnant or woman of child-bearing potential 7. The woman under breast-feeding 8. Patients who were implanted metallic or electrical devices 9. Patients who are judged as inappropriate for inclusion by physicians
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Koji Middle name Last name Kamagata
Organization	Juntendo University Graduated School of Medicine
Division name	Department of Radiology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	kkamagat@juntendo.ac.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Kamagata
Organization	Juntendo University Graduated School of Medicine
Division name	Department of Radiology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	kkamagat@juntendo.ac.jp

Sponsor
Institute	Department of Radiology, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	industry to support private universities building up their foundations of strategic research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo hospital ethics committee
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel	03-3813-3111
Email	kenkyu5858@juntendo.ac.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

Other administrative information
Date of disclosure of the study information	2014 Year 07 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	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 24 Day
Date of IRB	2014 Year 06 Month 20 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective study

Management information
Registered date	2014 Year 06 Month 26 Day
Last modified on	2019 Year 12 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016710