A Single-arm, Open-label, Single-center Clinical Study to Evaluate CDH3-targeted Positron Emission Tomography (PET) for Lung Malignant Tumors

What this Trial Is About

Lung malignant tumors, especially non-small cell lung cancer (NSCLC), are a major health concern worldwide due to their high incidence and mortality rates. Molecular imaging plays a vital role in early diagnosis, staging, prognosis, and treatment evaluation. This research focuses on a new PET probe, 68Ga-TOI-1, targeting Cadherin-3 (CDH3), a protein specifically expressed in cancerous lung epithelial cells, aiming to improve imaging accuracy over current methods like 18F-FDG PET. The study evaluates the use of the 68Ga-TOI-1 PET/CT scan alongside the standard 18F-FDG PET/CT in patients suspected of lung malignant tumors. Participants will undergo both scans within one week. The PET imaging involves tracer injection based on body weight and dynamic data acquisition for 60 minutes, with analysis performed by experienced radiologists. This single-arm, open-label study is designed to assess the diagnostic sensitivity and specificity of the CDH3-targeted probe and compare uptake values between the new and conventional imaging methods. Participants will be adults 18 years or older with suspected or confirmed lung cancer and a good performance status. They will undergo PET/CT scans, and researchers will collect clinical, imaging, and pathological data to analyze tracer uptake and correlation with tumor tissue markers. The primary outcome is the diagnostic accuracy of 68Ga-TOI-1 PET/CT within six weeks. Secondary outcomes include standardized uptake values and their correlation with CDH3 expression. The study includes safety monitoring and aims to provide precise evaluation tools for lung cancer diagnosis and staging.

Cadherin 3(CDH3)-Targeted PET in Lung Malignant Tumors