UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014389
Receipt No. R000016710
Scientific Title Pathophysiological analysis of Parkinson disease and related disorders using DAT scan and MRI
Date of disclosure of the study information 2014/07/01
Last modified on 2019/12/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000016710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.