Clinical trial NCT04017819: Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4
Official title: Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cancer
Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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).

Primary outcomes:
measure: Biodistribution of [18F]-C-SNAT4
timeFrame: 1 day
Secondary outcomes:
measure: Dosimetry of [18F]-C-SNAT4
timeFrame: 1 day
measure: Toxicity of [18F]-C-SNAT4
timeFrame: 7 days
measure: 18F]-C-SNAT4 Uptake
timeFrame: 1 day
measure: The Maximal [18F]-C-SNAT4 Uptake as PET Radiotracer
timeFrame: 1 day
measure: [18F]-C-SNAT4 PET Imaging Signal in Responders and Non-responders
timeFrame: 7 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei H Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References: