Cancer, Lung Cancer
Conditions
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.
Interventions
DRUG18F-C-SNAT4
Radiotracer- Dose 10 mCi
Positron emission tomography (PET)/Computed tomography (CT) Scan
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed