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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Neurodegenerative Dementia

Intervention / Treatment
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* Drug: 18F-S16


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Neurodegenerative Dementia Males and females, ≥40 years old They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists. Exclusion Criteria: Females planning to bear a child recently or with childbearing potential Renal function: serum creatinine >3.0 mg/dL (270 μM/L) Liver function: any hepatic enzyme level more than 5 times upper limit of normal. Known severe allergy or hypersensitivity to IV radiographic contrast. Patients not able to enter the bore of the PET/CT scanner. Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-S16 injection and PET/CT scan<br>The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection. | Drug: 18F-S16<br>* A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 hours | 
| Pulse | Pulse will be measured at three time points for each subjects: right before injection, after scanning, and 24 hours after treatment. | 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. | 24 hours | 
| Temperature | Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment. | 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. | 24 hours | 
| Serum albumin | Serum albumin of subjects will be measured at two time points: right before injection and 24 hours after treatment. | 24 hours | 
| Serum creatinine | Serum creatinine of subjects will be measured at two time points: right before injection and 24 hours after treatment. | 24 hours | 
| Adverse events collection | Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-S16, Neurodegenerative Dementia, PET/CT