UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014389
Receipt number 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 10:46:59

* 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 or person

Institute

Department of Radiology, Juntendo University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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