UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030084 |
|---|---|
| Receipt number | R000033376 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2018/03/29 15:59:21 |
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Basic information
Public title
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
Acronym
Practical evaluation of PET studies with three tracers for iPSC derived-neural transplantation
Scientific Title
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
Scientific Title:Acronym
Practical evaluation of PET studies with three tracers for iPSC derived-neural transplantation
Region
| Japan |
Condition
Condition
neuroinflammatory disorder, Parkinson's disease, Brain tumor
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the practicability of PET studies with [18F]-FDOPA, [18F]-GE180 and [18F]-FLT for a future clinical study of iPSC-based cell therapy for Parkinson's disease performed in Kyoto University Hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
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.
Key secondary outcomes
Safety of the PET studies with three tracers is assessed.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
[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
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1-a) [18F]-GE180 (4 subjects)
Subjects meet all the criteria below
i) showing clear mass sign with inflammation of CNS, demyelinated disorder or acute phase of brain infarction, which is diagnosed by history, MRI, and neurological assessment.
ii) aged above 50 y.o.
iii) ECOG Performance Status (PS) is 0 or 1
iv) subjects express its consent and sign on inclusion in the trial
1-b) [18F]-FDOPA
A) Parkinson's disease (2 subjects)
i) Diagnosed as Parkinson's disease by neurological assessment and DAT scan
ii) aged above 50 y.o.
iii) ECOG Performance Status (PS) is 0 or 1
iv) subjects express its consent and sign on inclusion in the trial
v) judged as safe regarding withdrawal of medication for Parkinson's disease
B) Healthy control (2 subjects)
Subjects meet the criteria i) or ii) and all from iii)-vii)
i) No abnormality is detected by the past MRI examination in Kyoto University Hospital
ii) Subjects with small intracranial aneurysms (<5mm) without any complication who is followed up annually with MRI in neurosurgical department.
iii) No neurological abnormality
iv) Aged above 50 y.o.
v) ECOG Performance Status (PS) is 0 or 1
vi) Subjects expresses its consent and sign on inclusion in the trial
1-c) [18F]-FLT (4 subjects)
Subjects meet all the criteria below
i) Diagnosed as primary brain tumor such as glioblastoma or metastatic brain tumor
ii) aged above 50 y.o.
iii) ECOG Performance Status (PS) is 0 or 1
iv) subjects express its consent and sign on inclusion in the trial
Key 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
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Takahashi |
Organization
Kyoto University
Division name
Center for iPS Cell Research and Application
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku,Kyoto 606-8507, JAPAN
TEL
075-366-7052
jbtaka@cira.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Morizane |
Organization
Kyoto University
Division name
Center for iPS Cell Research and Application
Zip code
Address
53 Kawahara-cho, Shogoin, Sakyo-ku,Kyoto 606-8507, JAPAN
TEL
075-366-7066
Homepage URL
morizane@cira.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033376
