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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016186
Receipt No. R000018773
Scientific Title Comparison of DaTscan with 3T-MRI for parkinson syndrome: prospective study
Date of disclosure of the study information 2015/01/13
Last modified on 2016/11/27

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Basic information
Public title Comparison of DaTscan with 3T-MRI for parkinson syndrome: prospective study
Acronym Comparison of DaTscan with 3T-MRI imaging for parkinson syndrome
Scientific Title Comparison of DaTscan with 3T-MRI for parkinson syndrome: prospective study
Scientific Title:Acronym Comparison of DaTscan with 3T-MRI imaging for parkinson syndrome
Region
Japan

Condition
Condition parkinson disease
Classification by specialty
Neurology Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this prospective study, we evaluated the use of DaTscan, 3T-MRI and clinical disease severity correlation for differential diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluated the signal variation in substantia nigra by 3T-MRI and dopamine transporter by DaTscan. These are evaluated from the clinical severity of classification within three months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy control
Patients who are suspected Parkinson disease and/or related disorders
Key exclusion criteria 1. Patients who are severe hepatic and/or renal dysfunction
2. Patients who are past history of hypersensitivity to Alcohol
3. Patients who are taking medicine which affects the uptake of I-123-Ioflupane
4. Patients who have voiding dysfunction
5. Pregnant or woman of child-bearing potential
6. The woman under breast-feeding
7. Patients who were implanted metallic or electrical devices
8. Patients who are judged as inappropriate for inclusion by physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumiko Kono
Organization Kansai Medical University
Division name Department of radiology
Zip code
Address 2-5-1 Shinmachi hirakata osaka
TEL 072-804-0101
Email kohnoy@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumiko Kono
Organization Kansai Medical University
Division name Department of radiology
Zip code
Address 2-5-1 Shinmachi hirakata osaka
TEL 072-804-0101
Homepage URL
Email kohnoy@hirakata.kmu.ac.jp

Sponsor
Institute Department of radiology, Kansai Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2015 Year 01 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2015 Year 01 Month 12 Day
Last modified on
2016 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018773

Research Plan
Registered date File name
2016/11/27 keikaku.umin.docx

Research case data specifications
Registered date File name
2016/11/27 Dat data.umin.xlsx

Research case data
Registered date File name
2016/11/27 Dat data.umin.xlsx


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