An Early Phase 1 interventional study of 18F-S16 in Neurodegenerative Dementia, sponsored by Oriental Neurosurgery Evidence-Based-Study Team. Status unknown at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Oriental Neurosurgery Evidence-Based-Study Team · Early Phase 1, Interventional, and Diagnostic
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 30 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Oriental Neurosurgery Evidence-Based-Study Team is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection.
Drug: 18F-S16
A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans
Semiquantitative assessment of lesions and biodistribution
The semiquantitative analysis will be performed by the same physician for all the cases, and the standardized uptake values (SUVs) of brain and other organs will be measured.
Time frame: One year
Blood pressure
Systolic and diastolic pressure of subjects will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Pulse
Pulse will be measured at three time points for each subjects: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Respiration frequency
Respiration frequency will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Temperature
Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Time frame: 24 hours
Serum alanine aminotransferase
Serum alanine aminotransferase of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum albumin
Serum albumin of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Serum creatinine
Serum creatinine of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Time frame: 24 hours
Adverse events collection
Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Time frame: 5 days
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Oriental Neurosurgery Evidence-Based-Study Team