Using 68GaGa-FAPI-46 PETCT to Detect Early Lymph Node Spread in Head and Neck Squamous Cell Carcinoma A Phase 2 Study Before Surgery

What this Trial Is About

Researchers are evaluating the use of 68GaGa-FAPI-46 PETCT imaging in patients with head and neck squamous cell carcinoma HNSCC to improve staging before surgery. The study focuses on cancer-associated fibroblasts CAFs, which contribute to metastasis by remodeling the tumor environment and promoting cancer spread. This trial aims to assess how 68GaGa-FAPI-46 PETCT can identify lymph nodes likely to develop metastases and to enhance tumor delineation in HNSCC patients. Participants will receive an intravenous injection of 68GaGa-FAPI-46 at a dose of 2 MBqkg, with the total dose ranging from 80 to 200 MBq. After about 60 minutes, a low-dose PETCT scan will be performed for approximately 20 minutes. This imaging will be added to the standard pre-surgical imaging protocol, which includes cervical MRI, contrast-enhanced CT, and 18F-FDG PETCT. The study compares PETCT imaging results with the pathology of resected lymph nodes to evaluate the ability of the imaging to detect premetastatic conditions. Participants will undergo standard pre-surgery imaging and lymph node dissection surgery as part of their care. The research team will analyze multiple imaging outcomes at 6 weeks, including tumor size, volume, SUVmax, number and location of lesions, and TNM tumor stage. Secondary outcomes include the ability of 68GaGa-FAPI-46 PETCT to visualize tumor infiltration in lymph nodes after 2 months. The total study duration extends through the surgery and follow-up imaging assessments. Safety and feasibility are monitored throughout the trial.

[68Ga]Ga-FAPI-46 in Staging of Head and Neck Carcinomas