Clinical trial · Interventional
Biodistribution & Pharmacokinetic of Position Emission Tomography (PET) Radiopharmaceutical 18F C SNAT4
Biodistribution and Pharmacokinetic Study of the Positron Emission Tomography (PET) Radiopharmaceutical [18F]-C-SNAT4
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-C-SNAT4 | Drug | — | UNRESOLVED |
| Positron emission tomography (PET)/Computed tomography (CT) Scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Healthy volunteers (Group 1)
- description
- 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).
- interventionNames
- Drug: 18F-C-SNAT4
- Device: Positron emission tomography (PET)/Computed tomography (CT) Scan
- type
- EXPERIMENTAL
- label
- Patients with newly diagnosed lung cancer (Group 2)
- description
- 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).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available