Evaluating a Novel 68Ga-PFD3 PETCT Scan Targeting DLL3 for Diagnosing and Assessing Small Cell Lung Cancer in Adults

What this Trial Is About

Researchers are evaluating the safety and performance of a new imaging probe called PFD3 to diagnose and assess small cell lung cancer SCLC. SCLC is an aggressive lung cancer subtype with rapid growth and early spread, making accurate staging critical for treatment decisions. Current PETCT imaging using 18F-FDG has high sensitivity but limited specificity, causing some patients to be incorrectly classified and potentially miss curative treatment options. PFD3 targets DLL3, a protein highly expressed in most SCLC cases, aiming to improve diagnostic accuracy and help select patients for DLL3-targeted therapies. The study involves sequential imaging using both the standard 18F-FDG PETCT and the novel 68Ga-PFD3 PETCT scans within one week for eligible patients. PFD3 is a nanobody-based probe designed for high specificity and rapid clearance, allowing same-day imaging. This trial compares the new probes diagnostic performance directly with the standard imaging and evaluates its safety in human subjects. Participants will undergo PETCT scans and have their DLL3 expression correlated with PFD3 uptake. Safety will be monitored for one week after injection through adverse event assessments. Researchers will also track progression-free survival for up to 12 months and overall survival over an average of 13 months. The study involves laboratory tests, imaging evaluations, and clinical follow-up to measure the probes diagnostic accuracy and patient outcomes.

68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer