UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Jun Takahashi
Organization	Kyoto University
Division name	Center for iPS Cell Research and Application
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	Asuka Morizane
Organization	Kyoto University
Division name	Center for iPS Cell Research and Application
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033376