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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030084
Receipt No. 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

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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
Email 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
Email morizane@cira.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033376

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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