Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4

Trial ID or NCT#

NCT04017819

Status

recruiting iconRECRUITING

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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * 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:
  1. * 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).
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Investigator(s)

Sanjiv Sam Gambhir, MD, PhD
Jianghong Rao

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Contact

David Marcellus
650-723-4547

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View on ClinicalTrials.gov