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

Study Overview
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Brief Summary
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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
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Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4

Conditions
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Cancer, Lung Cancer

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


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy volunteers (Group 1)<br>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). | Drug: 18F-C-SNAT4<br>* Radiotracer- Dose 10 mCi<br>Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan<br>* Positron emission tomography (PET)/Computed tomography (CT) Scan<br>|
| Experimental: Patients with newly diagnosed lung cancer (Group 2)<br>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). | Drug: 18F-C-SNAT4<br>* Radiotracer- Dose 10 mCi<br>Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan<br>* Positron emission tomography (PET)/Computed tomography (CT) Scan<br>|
| Experimental: Patients with lung cancer undergoing non-surgical tx (Group 3)<br>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) | Drug: 18F-C-SNAT4<br>* Radiotracer- Dose 10 mCi<br>Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan<br>* Positron emission tomography (PET)/Computed tomography (CT) Scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of [18F]-C-SNAT4 | Whole-body [18F]-C-SNAT4 PET scans will be performed at 60 min post intravenous injection of the PET tracer in Group 1 of 5 healthy volunteers | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetry of [18F]-C-SNAT4 | Radiation dosimetry of the [18F]-C-SNAT4 radiotracer will be measured through careful monitoring of each participant's vital signs in Group 1 and group 2. Time-Activity curves will be graphed by measuring activity in various organs using multiple PET/CT scans (1 hour dynamic scan, 1 hour and 2 hours) after tracer injection. Absorbed radiation will be calculated. | 1 day | 
| Toxicity of [18F]-C-SNAT4 | The acute [18F]-C-SNAT4 toxicity will be assessed as related adverse events, including laboratory abnormalities, that occur within 7 days of the infusion of [18F]-C-SNAT4. | 7 days | 
| 18F]-C-SNAT4 Uptake | The tumor uptake of [18F]-C-SNAT4 PET will be compared with the corresponding contralateral non-cancer tissue in patients with lung cancer before the therapy in Group 2 and 3. SUVmax measurements will be taken from the pre-treatment scan. | 1 day | 
| The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer | The time of maximal [18F]-C-SNAT4 radiotracer uptake post-injection will be assessed in Group 2 and 3. Time-Activity Curves (TAC) will be graphed by measuring activity in tumor after tracer injection. The maximal of [18F]-C-SNAT4 radiotracer uptake post-injection in lung cancer patients will be determined from these time activity curves. | 1 day | 
| [18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders | The [18F]-C-SNAT4 PET scan signal from pre-therapy to one week after initiation of therapy in Group 3 will be compared both in treatment responders vs. non-responders. SUVmax will be measured in both the pre-treatment and one-week post-initiation of treatment scans. | 7 days |