Tokyo, March 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061096) titled 'Investigation of Neurological Disease Pathophysiology Using Fluorine-18-Labeled SMBT-1 PET' on March 29.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Kagawa University
Condition:
Condition - neurological disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Patients with neurological disorders or suspected neurological conditions will undergo fluorine-18-labeled SMBT-1 PET imaging for the detection of monoamine oxidase B and the pathophysiological mechanisms of these disorders will be assessed based on tracer uptake.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Fluorine-18-labeled SMBT-1 will be intravenously administered at a dose of 3-5 MBq/kg and PET/CT imaging of the brain will be performed for 20 minutes beginning 50 minutes after injection.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - neurological disorder
Key exclusion criteria - articipants meeting any of the following criteria will be excluded:
Patients who are pregnant or may be pregnant
Patients with an urgent and life-threatening condition
Patients deemed unsuitable for the study by the investigator
Target Size - 500
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 03 Month 26 Day
Date of IRB - 2025 Year 03 Month 26 Day
Anticipated trial start date - 2026 Year 03 Month 30 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069911
Disclaimer: Curated by HT Syndication.
