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

• Status: Unknown status
• Trial end date: 2019-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oriental Neurosurgery Evidence-Based-Study Team

Criteria

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.