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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000016485 |
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Date of registration:
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09/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome
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Scientific title:
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Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome - PD-1 |
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Date of first enrolment:
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2015/02/25 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019141 |
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Study type:
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Interventional |
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Study design:
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Parallel Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Michio Senda |
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Address:
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2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
Japan |
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Telephone:
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078-304-5212 |
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Email:
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senda@fbri.org |
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Affiliation:
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Institute of Biomedical Research and Innovation Division of Molecular Imaging |
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Name:
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Akihito Ohnishi |
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Address:
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2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
Japan |
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Telephone:
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078-304-5212 |
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Email:
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ohnishi@fbri.org |
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Affiliation:
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Institute of Biomedical Research and Innovation Division of Molecular Imaging |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
35years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patients
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Intervention(s)
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Intravenous injection of 18F-fluoro-dopa and 11C-raclopride
PET imaging
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Primary Outcome(s)
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Integrated ratio of striatum and cerebellum cortex or the occipital lobe
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Secondary Outcome(s)
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Standard uptake value(SUV) of the striatum
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Source(s) of Monetary Support
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Foundation of Biomedical Research and Innovation
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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