Identification project data:
Program: RO-14 “Research in Priority Sectors”
Contract id number: 3SEE/30.06.2014
Project title: “NAVIGATION SYSTEM FOR CONFOCAL LASER ENDOMICROSCOPY TO IMPROVE OPTICAL BIOPSY OF PERIPHERAL LESIONS IN THE LUNGS – (NAVICAD)”
DoRIS code: RO14 – 0016
Funders: SEE 2009-2014 mechanism, state budget
Value: 4.840.106,1 RON
Contractor authority: Romanian National Ministry of Education
Contractor: University of Craiova
Coordinator – Universitatea din Craiova , Craiova, str. A. I. Cuza nr. 13, DOLJ, ROMANIA
P1 – Universitatea Politehnica din Bucuresti – CCMA, Splaiul Independentei, Sector 6, Bucuresti, Romania
P2 – Stiftelsen SINTEF represented by its institute Technology and society (SINTEF), Strindvegen 4, Trondheim, Norway
P3 – St. Olavs Hospital, Prinsesse Kristinas vei 3, Trondheim, Norway, N-7006
Currently, to diagnose a peripheral lung cancer, pulmonologists plan the transbronchial 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 a 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 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 (named NAVICAD) which uses a novel innovative steerable and electromagnetically tracked biopsy forceps with confocal fluorescence microscopy fiber (pCLE). To achieve this long-term goal, in the present proposal we plan to develop a working prototype of the NAVICAD system including an electromagnetically tracked biopsy forceps with pCLE fiber and test it in a custom-designed phantoms and large animals. After the successful completion of this project, the system will be further developed by the partners of this consortium for further phantom and animal studies, clinical trials and medical approvals.
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 will include a software module of computer-aided diagnosis (CAD) that will assist the bronchoscopist for pCLE image analysis for a fast decision to perform a tissue sampling.
The University of Craiova (UCV), the Project Promoter, and our partners from Norway (SINTEF (P2) and St. Olavs Hospital (P3)) have a track record of collaboration on developing methods to improve cancer diagnosis and treatment via minimally invasive medical devices [Manstad-Hulaas, 11], [Gruionu, 08], [Choi, 07], [Wong, 07]. The specific goals of this project are: 1) development of an innovative instrument for bronchoscopy with electromagnetically Tracked and Steerable Biopsy Forceps combined with an optical fiber from Cellvizio system, This instrument will be design and developed by UCV and SINTEF. 2) Design and implement a CAD system based on ANNs (artificial neural networks) to interpret FDs (fractal dimension) and lacunosity of pCLE images in real-time. This algorithm will be developed by UCV and Partner 1, the Univ. Politehnica of Bucharest (UPB). 3) Development of the NAVICAD software for hybrid imaging, navigation and virtual bronchoscopy by UCV and SINTEF and St. Olavs.
Pulmonologists will be able to use NAVICAD system with navigation and confocal microscopy to image lung tissue from proximal airways down to alveoli in patients presenting pulmonary lesions, to sample and, stage lung cancer as well as monitor the treatment.