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Sponsor: Stanford University
Conditions: Cancer, Lung Cancer
Interventions: 18F-C-SNAT4, Positron emission tomography (PET)/Computed tomography (CT) Scan
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * ANC ≥ 1.5 x 109/L without myeloid growth factor support for 7 days preceding lab assessment * 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 assessment * 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 Exclusion Criteria: * 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 scan. * 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).
- Stanford, California, United States