This study aims to investigate and evaluate the safety and performance of a novel probe, PFD3, for the diagnosis and assessment of patients with small cell lung cancer (SCLC).
Adults.
Histologically confirmed small cell lung cancer (SCLC).
At least one measurable lesion ≥1 cm in diameter (primary tumor, metastatic lesion, or involved lymph node) confirmed by standard imaging modalities.
Laboratory tests (complete blood count and biochemical analysis) completed within 4 weeks prior to enrollment.
Pregnancy.
Breastfeeding.
Acute psychiatric disorders.
Inability to undergo PET scanning (e.g., due to claustrophobia, weight limits, or other medical contraindications).
Single group
Sequential [18F]-FDG PET/CT
Diagnostic testBased on individual clinical circumstances, eligible patients will undergo sequential \[18F\]FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT scans within one week.
[68Ga]Ga-PFD3 PET/CT scan
Diagnostic testBased on individual clinical circumstances, eligible patients will undergo sequential \[18F\]FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT scans within one week.
Adverse events (assessed using CTCAE grades)
Post-injection, patients will be assessed for treatment-related adverse events at 24 hours and within one week, using CTCAE grades. The \[68Ga\]Ga-PFD3 PET/CT will be considered safe if no possible or confirmed, Grade 3 or higher adverse events are identified.
Correlation between PFD3 uptake and DLL3 expression
Quantitative assessment of DLL3 expression in patient biopsy lesions using immunohistochemistry will be correlated with uptake parameters from \[68Ga\]Ga-PFD3 PET/CT scans.
Imaging performance of [68Ga]Ga-PFD3 PET/CT
Including sensitivity, specificity, and other diagnostic metrics, in a head-to-head comparison with FDG.
Progression-free survival
Progression-free survival (PFS) is defined as the time from the date of baseline \[68Ga\]Ga-PFD3 PET/CT imaging to the date of first documented disease progression or death from any cause, whichever occurs first.
Overall Survival
Overall survival (OS) is defined as the time from the date of baseline PET/CT imaging to the date of death from any cause. Patients who are alive at the time of analysis will be censored at their last known alive date.
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