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

Phase 1

Active, not recruiting

• Conditions: Cancer; Lung Cancer
• Interventions: Drug: 18F-C-SNAT4; Device: Positron emission tomography (PET)/Computed tomography (CT) Scan

• Registration Number: NCT04017819
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2024-03-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers (Group 1)	18F-C-SNAT4	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).
Healthy volunteers (Group 1)	Positron emission tomography (PET)/Computed tomography (CT) Scan	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).
Patients with newly diagnosed lung cancer (Group 2)	18F-C-SNAT4	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).
Patients with newly diagnosed lung cancer (Group 2)	Positron emission tomography (PET)/Computed tomography (CT) Scan	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).
Patients with lung cancer undergoing non-surgical tx (Group 3)	18F-C-SNAT4	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)
Patients with lung cancer undergoing non-surgical tx (Group 3)	Positron emission tomography (PET)/Computed tomography (CT) Scan	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)

Primary Outcome Measures

Name	Time	Method
Biodistribution of [18F]-C-SNAT4	1 day	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

Secondary Outcome Measures

Name	Time	Method
Dosimetry of [18F]-C-SNAT4	1 day	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.
Toxicity of [18F]-C-SNAT4	7 days	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.
18F]-C-SNAT4 Uptake	1 day	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.
The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer	1 day	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.
[18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders	7 days	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States