[68Ga]Ga-FAPI-46 PET/CT in Early Detection of Lymph Node Metastasis in Head and Neck Squamous Cell Carcinomas

What this Trial Is About

Researchers are evaluating the use of [68Ga]Ga-FAPI-46 PET/CT 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 [68Ga]Ga-FAPI-46 PET/CT can identify lymph nodes likely to develop metastases and to enhance tumor delineation in HNSCC patients. Participants will receive an intravenous injection of [68Ga]Ga-FAPI-46 at a dose of 2 MBq/kg, with the total dose ranging from 80 to 200 MBq. After about 60 minutes, a low-dose PET/CT 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 PET/CT. The study compares PET/CT 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 [68Ga]Ga-FAPI-46 PET/CT 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