Description
Currently, to diagnose a peripheral lung cancer, pulmonologists examine a number of Computed Tomography scans, insert a biopsy forceps through bronchoscope, and blindly perform the biopsy. Consequently, 43%-95% of the procedures fail to reach peripheral targets, depending on size and location. We propose to overcome these limitations and enhance the accuracy and guidance, together with the option of a preliminary optical diagnosis on biopsy site. This main objective will be attained by developing an innovative minimally invasive image-guided system (NAVICAD) with confocal microscopy. The project will develop a novel innovative steerable and electromagnetically tracked biopsy forceps with confocal fluorescence microscopy fiber (pCLE) and a module of computer aided diagnostic. The target groups are patients with periferal lung lessions or suspected tissue formations. The University of Craiova (UCV), the Project Promoter, University Politehnica of Bucharest (UPB, Partner 1) and our partners from Norway (SINTEF – Partner 2) and St. Olav's Hospital (Partner 3) will strengthen their traditional collaboration on developing methods to improve cancer diagnosis and treatment via minimally invasive medical devices. The results will be an innovative instrument for bronchoscopy with optical fiber from Cellvizio system, a computer aided diagnostic module, and the NAVICAD software for hybrid imaging.
Summary of project results
Currently, to diagnose a peripheral lung cancer, pulmonologists plan the trans-bronchial biopsy procedure by examining a number of Computed Tomography (CT) scan slices before the procedure. They then manipulate a flexible video bronchoscope into lobe and sub-segmental bronchi as far as the diameter of the bronchoscope permits. Finally, they insert biopsy forceps through the working channel of the bronchoscope, and blindly perform the biopsy. Consequently, 43%-95% of the procedures fail to reach peripheral targets, depending on size and location. When these failures occur, pulmonologists must repeat the procedure or follow up with more invasive methods that have increased complication rates, such as CT-guided percutaneous needle biopsy with increased level of radiation for surgeon and patient or surgical biopsy with high stress for patient. We successfully overcome these limitations and enhanced the accuracy and guidance, together with the option of a preliminary optical diagnosis on biopsy site. This main objective attained by the project was to develop an innovative minimally invasive image-guided system (named NAVICAD) which uses a novel innovative steerable and electromagnetically tracked biopsy forceps with confocal fluorescence microscopy fiber (pCLE). To achieve this goal, we developed a working prototype of the NAVICAD system including an electromagnetically tracked biopsy instrument with pCLE fiber and we successfully test it in a custom-designed phantoms and large animals. The project was successfully completed, and for the future, we planned further development by the partners of this consortium for animal studies, clinical trials and medical approvals. The first clinical trial on human patients for part of the NAVICAD system was approved in Norway and will start in 2018. Fibered confocal fluorescence microscopy allows physicians to examine potential lung cancers and other disease on-site before a biopsy and has the magnification that can see individual cell in pulmonary tissue. Therefore it has the potential to prevent more invasive procedures, identify infections and malignant diseases and non-invasively monitor of the treatment for a mass in the airways. The NAVICAD system includes a software module of computer-aided diagnosis (CAD) that assist the bronchoscopist for pCLE image analysis for a fast decision to perform a tissue sampling.
Summary of bilateral results
The NAVICAD consortium have a major interest in developing this system, as a concluding result of more than a 6 years’ collaboration in the research of hybrid imaging and navigation system from bronchoscopy proved by previous grants and publications. This innovative system we developed as a full working prototype during this project and will be further clinically tested and prepared for market by a spin-off developed by our consortium. In NAVICAD, SINTEF together with University of Craiova and Politehnica University of Bucharest, has focused on developing an open source image guided bronchoscopy navigation system based on iterative specifications from pulmonologists and in collaboration with the Romanian team. The preclinical testing of the NAVICAD catheter developed by Romanian team was successful tested in a live animal trial in Trondheim in 2017. For the guidance part of the NAVICAD platform, Norwegian partners in collaboration with the Romanian team refined and tested in the clinic an intraoperative registration method for automatically performing CT-to-patient based registration during the initial phase of the bronchoscopy, i.e. the sedation of the airways. Based on the diversity of objectives, with interfering clinical and experimental aims, there is a certain added value of working together in the partnership, with clear impact towards both the clinical sector (through the expected development of a novel investigation system for focal lung masses) and also towards the medical industry applications. The future commercialization of the products at national and European level will be decided by Romanian and Norway partners and will be supported by a spin-off that will result from this project. St. Olavs Hospital has contributed in all phases of the project together with both the technological team at SINTEF and in Romania. In the clinic we have been able to test equipment in realistic setting, assess the accuracy and feasibility and also study the visualization solutions during real patient procedures when the NAVICAD planning and guidance system is used alongside the conventional systems used for bronchoscopy and sampling of peripheral lesions. The clinical goal is to increase the success rates of biopsies using better planning and guidance system developed by the Norway-Romania team collaboration.