search
Back to results

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

Primary Purpose

Neurodegenerative Dementia

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-S16
Sponsored by
Oriental Neurosurgery Evidence-Based-Study Team
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neurodegenerative Dementia focused on measuring 18F-S16, Neurodegenerative Dementia, PET/CT

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • PET/CT center,Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-S16 injection and PET/CT scan

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2018
Last Updated
August 3, 2018
Sponsor
Oriental Neurosurgery Evidence-Based-Study Team
search

1. Study Identification

Unique Protocol Identification Number
NCT03620552
Brief Title
18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia
Official Title
Safety and Diagnostic Performance of 18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
October 20, 2018 (Anticipated)
Study Completion Date
February 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oriental Neurosurgery Evidence-Based-Study Team

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodegenerative Dementia
Keywords
18F-S16, Neurodegenerative Dementia, PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-S16 injection and PET/CT scan
Arm Type
Experimental
Arm Description
The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection.
Intervention Type
Drug
Intervention Name(s)
18F-S16
Intervention Description
A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans
Primary Outcome Measure Information:
Title
Semiquantitative assessment of lesions and biodistribution
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic pressure of subjects will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Pulse
Description
Pulse will be measured at three time points for each subjects: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Respiration frequency
Description
Respiration frequency will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Temperature
Description
Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Time Frame
24 hours
Title
Serum alanine aminotransferase
Description
Serum alanine aminotransferase of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Serum albumin
Description
Serum albumin of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Serum creatinine
Description
Serum creatinine of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Time Frame
24 hours
Title
Adverse events collection
Description
Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Cai, MD
Phone
86-22-60362190
Email
XCL242004@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Cai, MD
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
PET/CT center,Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Cai, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs