NCT03620552

18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia

Safety and Diagnostic Performance of 18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-S16 in healthy volunteers and patients with neurodegenerative dementia.

Detailed description

For interests in clinical translation of 18F-S16, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 18F-S16 in patients with neurodegenerative dementia. A single dose of nearly 370 MBq 18F-S16 will be intravenously injected into healthy volunteers and patients with neurodegenerative dementia. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the subjects. Adverse events will also be observed in the subjects.

Conditions

• Neurodegenerative Dementia

Interventions

Type	Name	Description
DRUG	18F-S16	A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans

Timeline

• Start date: 2017-08-20
• Primary completion: 2018-10-20
• Completion: 2019-02-20
• First posted: 2018-08-08
• Last updated: 2018-08-08

Locations

1 site across 1 country: China