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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 [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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030084
Enrollment
12
Registered
2017-12-01
Start date
2017-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroinflammatory disorder, Parkinson&#39

Interventions

[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 MB

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Safety of the PET studies with three tracers is assessed.

Countries

Japan

Contacts

Public ContactAsuka Morizane

Kyoto University Center for iPS Cell Research and Application

morizane@cira.kyoto-u.ac.jp075-366-7066

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026