Optimizing Oral Cancer Surgery Using Real-time Fluorescence Imaging with cRGD-ZW800-1

What this Trial Is About

Researchers are investigating the use of intraoperative Fluorescence Imaging FLI with the agent cRGD-ZW800-1 to better assess tumor margins in patients with oral cancer. This phase 2 clinical trial aims to determine the best dose of the agent for imaging and to evaluate if FLI can improve surgical removal accuracy. The study also examines the precision and safety of this imaging method during surgery for squamous cell carcinoma of the oral cavity. The trial is divided into two parts. In the first part, two dose groups receive different amounts of cRGD-ZW800-1 before surgery to find the dose that gives the clearest imaging signal. The first group receives 0.05 mgkg about 16 to 20 hours before surgery, and the second group will receive a dose determined based on initial results. In the second part, more patients receive the selected dose within 48 hours before surgery to test if FLI improves the rate of complete tumor removal and to study other outcomes such as operation time and lymph node imaging. Participants will undergo surgery with FLI and have their tumor margins assessed using imaging and pathology tests. Researchers will measure tumor-to-background signal ratios, the adequacy of tumor removal margins, and diagnostic accuracy through tissue analysis up to four weeks after surgery. The study involves monitoring surgical management changes, operation time, and examination of excised lymph nodes to understand the impact of FLI in oral cancer surgery.

Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer