Clinical trial NCT03620552: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Neurodegenerative Dementia
Keywords: 18F-S16
Neurodegenerative Dementia
PET/CT
Lead sponsor: Oriental Neurosurgery Evidence-Based-Study Team
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Semiquantitative assessment of lesions and biodistribution
timeFrame: One year
Secondary outcomes:
measure: Blood pressure
timeFrame: 24 hours
measure: Pulse
timeFrame: 24 hours
measure: Respiration frequency
timeFrame: 24 hours
measure: Temperature
timeFrame: 24 hours
measure: Serum alanine aminotransferase
timeFrame: 24 hours
measure: Serum albumin
timeFrame: 24 hours
measure: Serum creatinine
timeFrame: 24 hours
measure: Adverse events collection
timeFrame: 5 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: PET/CT center,Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Li Cai, MD
role: STUDY_DIRECTOR
References: