Detection of early esophageal cancer by near-infrared fluorescence molecular endoscopy
Esophageal cancer (EC) is the 8th most commonly diagnosed type of cancer worldwide, affecting more than 450,000 people, and the 6th leading cause of cancer-related death. Incidence rates are steeply rising due to the increasing prevalence of major risk factors, including obesity, chronic gastroesophageal reflux disease, and Barret’s esophagus (BE). Less than 20% 5-year survival rates are largely associated with the disease being detected late due to limitations in current diagnostic procedures. The current clinical-standard practice for early disease detection (i.e. surveillance endoscopy and random biopsies every 3-5 years) is sub-optimal and often misses dysplasia. Due to late detection, EC treatment 5-year costs may reach more than €130K per patient in Western countries. Conversely, detection and treatment of early-EC cancer is associated with very good prognosis (5-year survival rate of more than 90%) and treatment costs that are reduced to ~10% of the late-stage costs. For these reasons, early and accurate EC detection remains an unmet clinical need. ESCEND aims to shift the paradigm in EC early diagnosis and enhance current endoscopic performance by adding highly sensitive and quantitative fluorescence molecular endoscopy (FME) in real time. Based on exciting preliminary data using fluorescent agents targeting dysplasia and neoplasia and approved for experimental clinical use, ESCEND will advance evidence on minimally invasive FME, which is on the verge of clinical translation and with immense clinical impact and commercialization potential. FME promises to detect disease earlier, with higher specificity and sensitivity, and stratify disease in terms of cancer progression over the current state of the art. Thus, a central ambition of ESCEND is that a hybrid white-light and fluorescence endoscope will become the new BE diagnostic standard. ESCEND will: 1) statistically confirm previous pilot (Phase I) clinical data showing that the combination of high-definition white light endoscopy (HD-WLE) and FME using labelled bevacizumab improves early EC detection over the current clinical standard (i.e. HD-WLE and random biopsy) and: 2) validate EC biomarkers recently identified by genetic screening as targets for further improving EC detection and disease stratification over using labelled bevacizumab, based on retrospective analysis of BE patient specimen. Earlier detection and better stratification can lead to more effective therapy and thus save lives and healthcare costs. Therefore, successful implementation of ESCEND could lead to an enormous socio-economic impact.
Funded by the European Union under the Horizon Europe Framework Programme - Grant Agreement Nº: 101095654. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.