UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016186 |
|---|---|
| Receipt number | 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 20:13:53 |
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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
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
kohnoy@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of radiology, Kansai Medical University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/18773
