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

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

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.

Study Overview

• Status: Unknown
• Conditions: Neurodegenerative Dementia
• Intervention / Treatment: Drug: 18F-S16

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Li Cai, MD; Phone Number: 86-22-60362190; Email: XCL242004@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • PET/CT center,Tianjin Medical University General Hospital
      • Contact: Li Cai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 18F-S16; A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oriental Neurosurgery Evidence-Based-Study Team
• Investigators: Study Director: Li Cai, MD, Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Anticipated): October 20, 2018
• Study Completion (Anticipated): February 20, 2019

Study Registration Dates

• First Submitted: July 29, 2018
• First Submitted That Met QC Criteria: August 3, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: PET/CT; 18F-S16; Neurodegenerative Dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: S16AD2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No