UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome
Title of the study (Brief title)	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	Michio Senda
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL	078-304-5212
Email	senda@fbri.org

Public contact
Name of contact person	Akihito Ohnishi
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Published in Ann Nucl Med 2017; 31:163-171,
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