E!11581 Image-guided catheter navigation in the outer airways

Lung cancer is the leading cause of cancer-related deaths in the world, both for women and men. Delayed investigation and treatment is an important cause, as patients in early stages have few symptoms. Most patients who are investigated for suspected lung cancer are older, mostly smokers, with comorbid conditions. This requires gentle and time-efficient procedures. Accurate and efficient diagnostic staging methods are important to make sure that the patient gets the appropriate treatment for that particular lung cancer subtype and stage. Tissue samples are needed to confirm whether the patient has cancer, and what type. Bronchoscopy, endoscopic camera examination of the lungs, is the most important tool for obtaining such tissue samples. The main reason for a delay in investigation is failure to sample the suspected lesion, which may result in several weeks postponement before diagnosis. Unfortunately, bronchoscopy has a very low success rate in the outer parts of the lungs. This is where we often find early lung cancer that can be cured. It is therefore imperative that the first sampling is optimal. To achieve this the physicians need appropriate tools in the planning phase and access to all available radiological information during the diagnostic procedure. SINTEF Technology and society, Medical Technology, and the company Ceetron AS in Trondheim, collaborated with partners in the Netherlands and Ireland on the project to develop a better technical solution for tissue sampling in the lungs, especially in the outer parts of the airways. The project Mariana dealt with both a new traceable and steerable flexible tool (catheter) and software to improve the planning and guidance of bronchoscopic procedures. In addition to the system, a business plan has been developed.

A novel platform for navigated bronchoscopy: - A new flexible catheter for steering in the peripheral lung airways - A new open API tracking system - A new software platform for planning and guidance of bronchoscopy Business plan for establishing a company MARIANA Medical for commercialization of the prototype.

The main result of the project will be more accurate, more effective and less expensive management of early stage lung cancer. Increased accuracy will be achieved through significant progress beyond the current state of the art in image-guidance and tracking technology. The working channel of our tracked catheter facilitates deployment of the most advanced diagnostic imaging technology in the airways such as endobronchial ultrasound and emerging imaging modalities such as optical coherence tomography. While currently available technology does not enable real-time diagnosis and therapy, advanced imaging when used in conjunction with instrument tracking has been shown to improve diagnostic outcomes. Our catheter channel enables immediate endoluminal probe therapy using high-impact developmental technologies such as photodynamic therapy, cryotherapy and electrochemotherapy without the need for a separate procedure. The image-guidance platform will reduce biopsy costs by enabling endoluminal approaches to nodules which are now subject to surgical biopsy. Wireless electromagnetic navigation is facilitated with machine-learned predictive software mapping of lumens in the outer airways using the CustusX platform technology. Real-time patient motion tracking will facilitate compensation of tracking errors due to breathing and patient movement. Based on novel lumen extraction algorithms and registration techniques, we will develop and produce a cloud-based software tool for planning and guiding procedures. We envisage significant navigation capabilities beyond the current commercial standard of 6-8 airway branches with endoluminal navigation in up to 12 airway branches.