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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017819
• Other study ID #: IRB-49038
• Secondary ID: LUN0108IRB-49038
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 7, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: David Marcellus
• Phone: 650-723-4547
• Email: dmarcel2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Lung Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	[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