©2022 Stanford Medicine
Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4
Trial ID: NCT04017819
Primary Objectives - Determine the biodistribution of [18F]-C-SNAT4 in 5 healthy volunteers. Secondary Objectives - Determine the dosimetry of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer. - Determine the acute toxicity of [18F]-C-SNAT4 PET in healthy volunteers and patients with lung cancer. - Determine whether uptake in [18F]-C-SNAT4 PET imaging is significantly different in tumor and corresponding contralateral noncancer tissue in patients with lung cancer (tested by Wilcoxon test) before the therapy. - Determine/verify the safety profile of the [18F]-C-SNAT4 radiotracer, as an imaging agent in patients with lung cancer. - Determine the time of maximal [18F]-C-SNAT4 radiotracer uptake post injection.
Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
- ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab
- Hgb ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb corrected to ≥ 9 g/dL
(90 g/L) as by growth factor or transfusion prior to PET scan
- Platelet count ≥ 100 x 109/L w/o blood transfusions for 7 days preceding lab
- Bilirubin ≤ 1.5 x upper limit of normal (ULN) except for pts with documented history
of Gilbert's disease
- ALT ≤ 2.5 x ULN
- AST ≤ 2.5 x ULN
- Alkaline phosphatase (AP) ≤ 3 x ULN
- If a women of childbearing potential (WCBP): negative early pregnancy test (EPT)
- Karnofsky Performance Status (KPS) ≥ 60
- Ability to understand and the willingness to sign a written informed consent document
- Has already begun non-surgical therapy for any recurrence, prior to the first
[18F]-C-SNAT4 PET/CT scan
- Severe/uncontrolled inter-current illness within the previous 28 days prior to PET
- Any other significant co-morbid conditions that in the opinion of the Investigator
would impair study participation or cooperation.
- History of allergic reactions to IV contrasts or reactions attributed to compounds of
similar chemical or biological composition to [18F]-C-SNAT4 used in study.
- Pregnant or nursing
- Patients who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot
fit through the PET/CT bore (diameter 70 cm).
procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan
School of Medicine
300 Pasteur Drive
Stanford, CA 94305