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

Stanford University

Status and phase: Suspended; Phase 1

Conditions: Lung Cancer; Cancer

Treatments: Drug: 18F-C-SNAT4; Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04017819

IRB-49038 (Other Identifier)

LUN0108 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Healthy volunteers (Group 1)

Active Comparator group

Description:

Group 1(n = 5) healthy volunteers. Each participant in this part of the study will receive a single dose of \[18F\]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of \[18F\]-C-SNAT4).

Treatment:

Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Drug: 18F-C-SNAT4

Patients with newly diagnosed lung cancer (Group 2)

Experimental group

Description:

Group2 (n = 5) newly diagnosed lung cancer. Each participant in this part of the study will receive a single dose of \[18F\]-C-SNAT4 and then undergo three times of whole body (WB) PET/CT scans (Scan 1: 60 minutes dynamic scan; Scan 2: WB skull base-thigh at 90 minutes +/- 10 minutes post injection; Scan 3: WB skull base-thigh at 120 minutes +/- 10 minutes post-injection of \[18F\]-C-SNAT4).

Treatment:

Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Drug: 18F-C-SNAT4

Patients with lung cancer undergoing non-surgical tx (Group 3)

Experimental group

Description:

Group 3 (n = 10) lung cancer after non-surgical therapy. Each participant in this part of the study will receive a total of 2 doses of \[18F\]-C-SNAT4 (on 2 separate occasions spaced at least 1 week apart, each of which will be followed by undergoing a \[18F\]-C-SNAT4 PET/CT scan)

Treatment:

Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

Drug: 18F-C-SNAT4