Neurodegenerative Dementia Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | February 20, 2019 |
| Est. primary completion date | October 20, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | PET/CT center,Tianjin Medical University General Hospital | Tianjin | Tianjin |
| Lead Sponsor | Collaborator |
|---|---|
| Oriental Neurosurgery Evidence-Based-Study Team |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | Pulse | Pulse will be measured at three time points for each subjects: right before injection, after scanning, and 24 hours after treatment. | 24 hours | |
| Secondary | 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 | |
| Secondary | Temperature | Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment. | 24 hours | |
| Secondary | 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 | |
| Secondary | Serum albumin | Serum albumin of subjects will be measured at two time points: right before injection and 24 hours after treatment. | 24 hours | |
| Secondary | Serum creatinine | Serum creatinine of subjects will be measured at two time points: right before injection and 24 hours after treatment. | 24 hours | |
| Secondary | Adverse events collection | Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed. | 5 days |