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

NCT03620552 | Unknown Early Phase 1

• 1 other identifier: S16AD2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Dementia

Keywords

18F-S16; Neurodegenerative Dementia; PET/CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Blood pressure

  24 hours

• Pulse

  24 hours

• Respiration frequency

  24 hours

• Temperature

  24 hours

• Serum alanine aminotransferase

  24 hours

Study Arms (1)

18F-S16 injection and PET/CT scan

EXPERIMENTAL

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

Drug: 18F-S16

Interventions

18F-S16 DRUG

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

18F-S16 injection and PET/CT scan

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oriental Neurosurgery Evidence-Based-Study Team: lead

Study Sites (1)

PET/CT center,Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Study Officials

• Li Cai, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Li Cai, MD

CONTACT

86-22-60362190; XCL242004@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2018
• First Posted: August 8, 2018
• Study Start: August 20, 2017
• Primary Completion: October 20, 2018
• Study Completion: February 20, 2019
• Last Updated: August 8, 2018

Record last verified: 2018-06

Locations

CN (1)