Image Guided Surgery for Margin Assessment of Head and Neck Cancer Using Cetuximab-IRDye800CW cONjugate
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Surgery remains a main pillar in the treatment of head and neck squamous cell carcinoma
(HNSCC). The margin status is the main prognostic factor of local tumor control in surgically
treated HNSCC and will determine the postoperative treatment strategy. A margin of ≤1 mm of
normal tissue is considered a positive margin and requires either a re-operation or
postoperative chemoradiation with a combination of cisplatin and 5-FU, which substantially
increases morbidity. Margins wider than 1 mm but less than 5 mm require re-operation, or, if
that is not possible, post-operative radiotherapy without the concomitant use of
chemotherapy. Currently, no technology is available in the operating room, which reliably
supports tumor excision in terms of margin status. In fact, surgeons can only combine pre-
operative imaging data with tactile and visual information during surgery for assessing tumor
margins with limited accuracy. With the introduction of molecular imaging techniques using
near infrared (NIR) fluorescent optical contrast agents coupled to targeted compounds, new
avenues have opened up for intra-operative assessment of tumor margins. Tracers are based on
antibodies directed against Vascular Endothelial Growth Factor-A, i.e.
bevacizumab-IRDye800CW, in patients with breast cancer or against Epidermal Growth Factor
Receptor, i.e. cetuximab-IRDye800CW, in patients with HNSCC. First trials have shown that
systemic administration of these compounds is safe and tumor specific. These findings
prompted us to design this innovative application in a clinical trial for the intraoperative
assessment of tumor margins during surgical treatment of HNSCC using cetuximab-IRDye800CW.