OPTIMIST studyOPtical Imaging for lymph node metastatic guidance in Minimally InvaSive esophagecTomy
AimsIn operable patients suffering from esophageal adenocarcinoma (EAC), surgical resection of the tumor in combination with a two-field lymph node resection after neoadjuvant chemoradiotherapy (nCRT) is considered the cornerstone of intentionally curative treatment. However, only 30% of patients are diagnosed post-operatively with lymph node metastases, which implies that in 70% of patients no lymph node metastases are present. In these cases restricted surgery, local endoscopic procedures (ie. EMR/ESD) or even a ‘wait and see’ policy could be less harmful alternatives.
There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for esophageal cancer. Optical molecular imaging of esophageal adenocarcinoma (EAC) associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is over expressed in esophageal adenocarcinoma and its lymph node metastases and has proven to be a suitable target for molecular imaging. We hypothesize that the VEGF-targeting antibody Bevacizumab labeled with the fluorophore IRDye800CW (Bevacizumab-800CW) accumulates in VEGF-A expressing cancer, enabling esophageal cancer visualization using a NIR minimally invasive intra-operative camera system.
In this pilot intervention study we will determine the optimal dosage of Bevacizumab-800CW (4.5, 10 or 25 mg) to detect esophageal cancer tissue intra-operatively. The aim of the present feasibility study is to determine the safety and feasibility to detect residual disease in esophageal tumor and lymph nodes during surgery.
Research within MITeCNear-infrared (NIR) fluorescence technology (available within MITeC) combined with GMP produced fluorescent tracers will be used to study the efficacy of tumor specific fluorescent imaging in intra-operative diagnosing lymph node metastases. A method of real-time intra-operative distinction of the absence or presence of loco-regional lymph node metastases in solid tumors will be a major breakthrough in the field of surgical oncology. With such a technique it might be possible to personalize treatment strategy, prevent morbidity and consequently save costs.
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