Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Institutes of Health (NIH)

Stanford Investigator(s):

Intervention(s):

  • Drug: 18F-C-SNAT4
  • Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan

Phase:

Phase 1/Phase 2

Eligibility


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).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Risa Jiron
Not Recruiting