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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016485
Receipt No. R000019141
Scientific Title Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome
Date of disclosure of the study information 2015/02/09
Last modified on 2018/01/24

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Basic information
Public title Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome
Acronym PD-1
Scientific Title Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome
Scientific Title:Acronym PD-1
Region
Japan

Condition
Condition Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients
Classification by specialty
Neurology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Basic data acquisition of PET image of 18F- fluoro-dopa and 11C- raclopride in healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients
Basic objectives2 Others
Basic objectives -Others Data acquisition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Integrated ratio of striatum and cerebellum cortex or the occipital lobe
Key secondary outcomes Standard uptake value(SUV) of the striatum

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Intravenous injection of 18F-fluoro-dopa and 11C-raclopride
Interventions/Control_2 PET imaging
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
35 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy
over 35 years old
Subjects who do not have clinically abnormal findings in the head MRI
Subjects who informed consent was obtained
Sbjects who do not have healthy problem to participate in clinical research

Parkinson's disease/Parkinson's syndrome
over 35 years old
Sbjects who has been diagnosed with Parkinson's disease or Parkinson's syndrome clinically
Subjects who have normal finding or do not have organic lesions to doubt Parkinson's syndrome associated with the central nervous system degenerative disease in MRI imaging
Subjects who informed consent was obtained
Sbjects who do not have healthy problem to participate in clinical research
Key exclusion criteria Subjects who consciousness is not clear
Subjects with cerebrovascular disorder
Subjects with cardiac dysfunction
Subjects with QT prolongation and ventricular arrhythmias on the electrocardiogram
Subjects with liver and kidney failure
Subjects with gastric ulcer and duodenal ulcer
Subjects with diabetes
Subjects with serious lung disease, bronchial asthma and endocrine disease
Subjects with angle-closure glaucoma and chronic open-angle glaucoma
Subjects who are psychiatric symptoms such as suicidal tendencies
Subjects who are taking non-selective monoamine oxidase inhibitors
Subjects who suffer from the symptomatic parkinsonism by clear organic cause
Subjects who have the history of drug allergy
Subjects who it is difficult to skip Parkinson treatment medicine from the day before
Subjects with rhabdomyolysis
Subjects with malignant syndrome
Subjects with pheochromocytoma
Subjects with prolactin-secreting pituitary tumor
Subjects who are dehydration and malnutrition state
Subjects Who exhibit a strong response to drink
Subjects who are drug dependence, alcohol dependence
Subjects who have participated in clinical research within the past 3 months
Subjects who reserchers judged as inappropriate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Senda
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5212
Email senda@fbri.org

Public contact
Name of contact person
1st name
Middle name
Last name Akihito Ohnishi
Organization Institute of Biomedical Research and Innovation
Division name Division of Molecular Imaging
Zip code
Address 2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL 078-304-5212
Homepage URL
Email ohnishi@fbri.org

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
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 先端医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Published in Ann Nucl Med 2017; 31:163-171,
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 Completed
Date of protocol fixation
2014 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 09 Day
Last modified on
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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