Neurodegenerative Dementia
Conditions
Keywords
18F-S16, Neurodegenerative Dementia, PET/CT
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.
Interventions
DRUG18F-S16
A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans
Sponsors
Oriental Neurosurgery Evidence-Based-Study Team
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Temperature | 24 hours | Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment. |
| 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. |
| Serum albumin | 24 hours | Serum albumin of subjects will be measured at two time points: right before injection 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. |
| 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. |
Countries
China
Contacts
Primary ContactLi Cai, MD
Outcome results
None listed