Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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).

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT04017819

Recruitment Status:

Not yet recruiting

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University
Stanford California, 94304, United States More Info
Risa Jiron
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT04017819

Recruitment Status:

Not yet recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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