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

Oriental Neurosurgery Evidence-Based-Study Team

Status and phase: Unknown; Early Phase 1

Conditions: Neurodegenerative Dementia

Treatments: Drug: 18F-S16

Study type: Interventional

Funder types: Other

Identifiers

NCT03620552

S16AD2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with Neurodegenerative Dementia
2. Males and females, ≥40 years old
3. 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

1. Females planning to bear a child recently or with childbearing potential
2. Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
3. Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
4. Known severe allergy or hypersensitivity to IV radiographic contrast.
5. Patients not able to enter the bore of the PET/CT scanner.
6. Inability to lie still for the entire imaging time because of cough, pain, etc.
7. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
8. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

18F-S16 injection and PET/CT scan

Experimental group

Description:

The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection.

Treatment:

Drug: 18F-S16