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

NCT ID: NCT03620552

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2019-02-20

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-S16 injection and PET/CT scan

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

Group Type: EXPERIMENTAL

18F-S16

Intervention Type: DRUG

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

Interventions

18F-S16

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oriental Neurosurgery Evidence-Based-Study Team

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Cai, MD

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

PET/CT center,Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Cai, MD

Role: CONTACT

XCL242004@126.com

86-22-60362190

Facility Contacts

Li Cai, MD

Role: primary

Other Identifiers

S16AD2018

Identifier Type: -

Identifier Source: org_study_id