Phase 1 Study of 111In Panitumumab Imaging to Detect Lymph Node Spread in Head and Neck Squamous Cell Carcinoma Patients Undergoing Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of indium In 111 panitumumab 111In-panitumumab in identifying sentinel lymph nodes in patients with head and neck squamous cell carcinoma HNSCC undergoing surgery. This phase I trial focuses on detecting lymph node metastases, which greatly affect survival rates, by using a radioactive drug linked to an antibody that binds to tumor cells. The drugs uptake is visualized with SPECTCT imaging to potentially improve lymph node detection compared to current methods. Participants receive a loading dose of panitumumab intravenously over 15 minutes, followed by an intravenous bolus of 111In-panitumumab on day 0. A SPECTCT scan is performed between day 1 and the day of surgery up to day 5. During standard surgery, patients receive a local injection of an optical dye and undergo intraoperative and near infrared imaging. Blood samples and electrocardiograms are collected at screening, on day 0, and on day 15 if needed. Throughout the study, researchers monitor safety by tracking adverse events up to 15 days after drug administration. They also compare the accuracy of 111In-panitumumab imaging with conventional local dye injection for sentinel lymph node detection. Participants are followed for safety and effectiveness assessments, including blood tests and imaging, until 15 days after the last dose. The total participation time is approximately two weeks.

Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer