Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4
Trial ID or NCT#
Status
RECRUITING
Purpose
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.
Official Title
Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
Eligibility 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
- - 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).
Investigator(s)
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Contact
David Marcellus
650-723-4547
View on ClinicalTrials.gov
