Study Protocol for Near-infrared Molecular Imaging for Lung Cancer Detection and Treatment During Mini-invasive Surgery (Phase II Trial) - (the RECOGNISE Study)

Lung cancer is the leading cause of cancer deaths in the European Union (EU) (267,000 deaths/year) and the fourth most common cancer (321,000 new cases/year). To date, radical surgery remains the best curative option in patients with early-stage lung cancer. Moreover, cancer screening programs have led to frequent diagnoses of indeterminate lung lesions, many requiring surgical biopsy for diagnosis and intervention.

For example, available data showed that 5.9 % of the European population over 15 years of age consumed at least 20 cigarettes per day (8.4 % in the male population), and around 12.6 % consumed less than 20. The recent lung cancer screening studies documented a prevalence of indeterminate pulmonary nodules as high as 50% in high-risk smokers, with a cancer detection rate in the overall screened population of 1%. Fascinatingly, 69% of screen-detected lung cancers were detected at early stage IA or IB.

Finally, studies on lung cancer screening, like the NELSON trial, showed a 26% reduction in lung cancer deaths at 10 years. The potential social impact of the present project is linked to establishing this screening program in Europe. One could estimate that if applied in the high-risk European population (i.e., high smokers), the screening could identify 3.5 million indeterminate pulmonary nodules, of which 250,000 are early-stage lung cancer. [2] Therefore, using the NIR-tracker the investigators propose could consent to a minimally invasive surgery in this scenario as a diagnostic and therapeutic procedure. Consequently, it could determine the reduction of time to diagnosis, morbidity, mortality, and costs of postoperative care associated with more invasive surgical procedures.

To date, lung anatomical resection with lymphadenectomy remains the best curative option in patients with early-stage non-small cell lung cancer. Moreover, cancer screening programs have led to frequent diagnoses of indeterminate lungs, many requiring surgical biopsy for diagnosis and intervention.

Nevertheless, the increase in the utilization of minimally invasive procedures (e.g., video-assisted thoracic surgery -VATS- and robotic-assisted thoracic surgery -RATS- ) remains mandatory in order to reduce the significant morbidity of classic surgery, the surgical trauma, to preserve organs function and to improve patient's quality of life. Nevertheless, minimally invasive surgery represents the surgical approach of choice in less than 40% of lung anatomical resections conducted in Europe. One of the significant issues that hinder the application of VATS and RATS to most early-stage NSCLC patients is the difficulty of recognizing lung nodules located deep in the lung parenchyma and, consequently, not visible with the traditional camera system. Indeed, VATS and RATS do not consent to manual lung palpation, making localizing the not superficial lung nodule problematic.