Status:
SUSPENDED
Biodistribution&Pharmacokinetic of Position Emission Tomography(PET) Radiopharmaceutical 18F C SNAT4
Lead Sponsor:
Stanford University
Conditions:
Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04017819
Start Date
March 7 2024
End Date
May 1 2026
Last Update
November 5 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304