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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-UMIN000030084 |
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Date of registration:
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01/12/2017 |
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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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Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease
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Scientific title:
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Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease - Practical evaluation of PET studies with three tracers for iPSC derived-neural transplantation |
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Date of first enrolment:
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2017/12/01 |
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Target sample size:
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12 |
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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=R000033376 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I,II
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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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Jun Takahashi |
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Address:
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53 Kawahara-cho, Shogoin, Sakyo-ku,Kyoto 606-8507, JAPAN
Japan |
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Telephone:
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075-366-7052 |
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Email:
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jbtaka@cira.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Center for iPS Cell Research and Application |
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Name:
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Asuka Morizane |
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Address:
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53 Kawahara-cho, Shogoin, Sakyo-ku,Kyoto 606-8507, JAPAN
Japan |
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Telephone:
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075-366-7066 |
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Email:
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morizane@cira.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Center for iPS Cell Research and Application |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: i) Having communication disorder ii) In severe general condition iii) Having severe infection or other severe complications iv) Having severe drug allergy v) Having difficulty in expression of consent vi) Pregnancy or possible pregnancy. During breast feed vii) Judged as inappropriate by doctors for other reasons in case of [18F]-GE180, [18F]-FLT viii) Surgical history on the site of the disease, which causes possible false-positive signal in case of [18F]-FDOPA ix) Difficulty in withdrawal of listed medication for Parkinson's disease due to medical reasons or dissent
Age minimum:
50years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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neuroinflammatory disorder, Parkinson's disease, Brain tumor
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Intervention(s)
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[18F]GE180 is injected intravenously as 3-4 MBq/Kg. PET is dynamically scanned for 90 minutes. Carbidopa 150mg is administrated orally 1hr before scan.[18F]FDOPA is injected intravenously as 3-4 MBq/Kg. Dynamic PET is scanned for 90 minutes. [18F]FLT is injected intravenously as 3-4 MBq/Kg. Statical PET is scanned after 60 minutes
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Primary Outcome(s)
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FLT PET detects malignant brain tumors. F-dopa PET detects dopamine neurons in healthy brains and decreased signal in Parkinsonian brains. GE180 PET detects neuroinflammatory disorders.
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Secondary Outcome(s)
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Safety of the PET studies with three tracers is assessed.
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Source(s) of Monetary Support
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AMED
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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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Yes |
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Date Posted:
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Date Completed:
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30/03/2018 |
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URL:
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