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

Biodistribution and Pharmacokinetic Study of the Positron 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Lung Cancer
• Intervention / Treatment: Drug: 18F-C-SNAT4; Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: David Marcellus; Phone Number: 650-723-4547; Email: dmarcel2@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: David Marcellus; Phone Number: 650-723-4547; Email: dmarcel2@stanford.edu
      • Principal Investigator: Andrei Iagaru, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers (Group 1); 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; Radiotracer- Dose 10 mCi; Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan; Positron emission tomography (PET)/Computed tomography (CT) Scan
Experimental: Patients with newly diagnosed lung cancer (Group 2); 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; Radiotracer- Dose 10 mCi; Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan; Positron emission tomography (PET)/Computed tomography (CT) Scan
Experimental: Patients with lung cancer undergoing non-surgical tx (Group 3); 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; Radiotracer- Dose 10 mCi; Procedure: Positron emission tomography (PET)/Computed tomography (CT) Scan; Positron emission tomography (PET)/Computed tomography (CT) Scan

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Andrei H Iagaru, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-49038 (Other Identifier: Stanford IRB); LUN0108 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No