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

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 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


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

Value
https://center6.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