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

NCT ID: NCT04017819

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2026-05-31

Brief 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.

Conditions

Cancer; Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

18F-C-SNAT4

Intervention Type: DRUG

Radiotracer- Dose 10 mCi

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

Intervention Type: DEVICE

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

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).

Group Type: EXPERIMENTAL

18F-C-SNAT4

Intervention Type: DRUG

Radiotracer- Dose 10 mCi

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

Intervention Type: DEVICE

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

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)

Group Type: EXPERIMENTAL

18F-C-SNAT4

Intervention Type: DRUG

Radiotracer- Dose 10 mCi

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

Intervention Type: DEVICE

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

Interventions

18F-C-SNAT4

Radiotracer- Dose 10 mCi

Intervention Type: DRUG

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

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrei H Iagaru, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

LUN0108

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-49038

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-49038

Identifier Type: -

Identifier Source: org_study_id