Targeting Delta-like Ligand 3 (DLL3) With 68Ga-PFD3 PET/CT for the Diagnosis and Assessment of Small Cell Lung Cancer

What this Trial Is About

Small cell lung cancer (SCLC) is a fast-growing and aggressive type of lung cancer that makes up about 15% of all lung cancers. It often spreads early and has a low survival rate for advanced stages. This trial evaluates a new imaging probe called PFD3, which targets a protein called DLL3 found in most SCLC cases, to improve diagnosis and staging compared to the current standard imaging method, [18F]-FDG PET/CT. The study aims to better distinguish limited-stage from extensive-stage disease to guide treatment options more accurately. Participants will undergo two diagnostic imaging scans within one week: the standard [18F]-FDG PET/CT and the new [68Ga]Ga-PFD3 PET/CT. PFD3 uses a specially designed small antibody fragment that binds specifically to DLL3, allowing targeted imaging of tumors. This same-day imaging approach may offer improved specificity and convenience. The trial will assess the safety and performance of the PFD3 probe and directly compare it with the existing FDG scan. During the study, researchers will monitor for any side effects one week after the PFD3 injection and measure how well the probe detects DLL3 expression in tumors at baseline. They will also evaluate imaging accuracy, track progression-free survival for up to 12 months, and monitor overall survival through study completion. Blood tests and other clinical assessments will be used to support these evaluations. The total involvement includes initial scans and follow-up for disease and safety monitoring.

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