Cerebral Blood Flow Measurement using PSO17

JRCT ID: jRCTs011180001

Registered date:12/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Epilepsy
• Date of first enrollment: 20/08/2019
• Target sample size: 10
• Study type: Interventional
• Intervention(s): administration of PSO17

Outcome(s)

• Primary Outcome: Agreement of localization of epileptic focus between cerebral blood flow images of PSO17 and FDG-PET

Secondary Outcome

1)Safety (vital signs, physical examinations, and adverse effects)
2) Signal changes in MRI

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

(1) Patients with symptomatic localized epilepsy who admitted Hokkaido University Hospital (pediatric ward or epilepsy center)
(2) From 16 to 64 years old when informed consent is obtained
(3) Body weight equal or less than 80 Kg
(4) At least one episode of epileptic seizure during one year before informed consent
(5) Focal cortical dysplasia, hippocampal sclerosis, cavernous angioma, DNT, or ganglioglioma was diagnosed on MRI
(6) epileptic focus is identified on electrophysiological studies (electroencephalography or magnetoencephalography) or functional brain imaging (FDG-PET or SPECT), and interictal FDG-PET was carried out within one year before informed consent or is scheduled within 6 months after obtaining informed consent.
(7) Written informed consent is obtained after sufficient explanation and full understanding

Exclude criteria

(1) Contraindication for MRI such as metallic implant (excluding MRI conditional devises), tattoo in the upper body, or claustrophobia
(2) Severe cardiovascular or renal dysfunction
(3) Unable to securing venous access
(4) Pregnant, suspected pregnancy, plan for pregnancy, refusing contraception including partner, or breast feeding
(5) Other reason for inadequacy to admit this study judged by principal investigator or co-investigators

Related Information

• Primary Sponsor: Kudo Kohsuke
• Source(s) of Monetary Support: Japan agency for medical research and development