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

Early Phase 1

• Conditions: Neurodegenerative Dementia
• Interventions: Drug: 18F-S16

• Registration Number: NCT03620552
• Lead Sponsor: Oriental Neurosurgery Evidence-Based-Study Team

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.

Study Timeline

• Study Start: 2017-08-20
• Status Verified: 2018-06
• Study First Submitted: 2018-07-29
• Study First Submitted QC: 2018-08-03
• Last Update Submitted: 2018-08-03
• Study First Posted: 2018-08-08
• Last Update Posted: 2018-08-08
• Primary Completion: 2018-10-20
• Study Completion: 2019-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Semiquantitative assessment of lesions and biodistribution	One year	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	24 hours	Systolic and diastolic pressure of subjects will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Temperature	24 hours	Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Serum creatinine	24 hours	Serum creatinine of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Adverse events collection	5 days	Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Pulse	24 hours	Pulse will be measured at three time points for each subjects: right before injection, after scanning, and 24 hours after treatment.
Respiration frequency	24 hours	Respiration frequency will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Serum alanine aminotransferase	24 hours	Serum alanine aminotransferase of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Serum albumin	24 hours	Serum albumin of subjects will be measured at two time points: right before injection and 24 hours after treatment.

Trial Locations

Locations (1)

PET/CT center,Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China