LX Medical — Department of Health and Human Services SBIR Phase I: NCI

Description

DESCRIPTION provided by applicant Recent technological advances have enabled low dose spiral CT to become an effective tool for lung cancer screening The majority of pulmonary nodules detected on CT however are small and difficult to diagnose While CT guided transthoracic needle biopsy CT TTNB has high diagnostic accuracy to depending on nodule size the risk of complications such as pneumothorax and bleeding is high Diagnostic confirmation by transbronchial lung biopsy using virtual bronchoscopy or electromagnetic navigation and endoscopic ultrasound is a safer alternative However the diagnostic yield is generally to lower than CT TTNB Current endoscopic ultrasound is limited by the size of the imaging probe spatial resolution and its inability to display blood vessels in the lesion Furthermore non solid lung nodules are not well visualized by ultrasound Owing to its large size the ultrasound probe cannot be inserted through a biopsy needle or catheter In lieu of this a guide sheath is used to extend the working channel to allow insertion of biopsy forceps after removing the ultrasound probe to take a biopsy without real time confirmation of the biopsy site Therefore there is an unmet clinical need for safe and accurate biopsy tools that can sample small pulmonary nodules under real time image guidance The goal of this project is to build and evaluate image guided biopsy tools to address this knowledge gap In Aim we will develop a small optical coherence tomography OCT catheter that combines Doppler OCT with autofluorescence sensitive imaging We will integrate these AF OCT imaging catheters with biopsy tools that will enable localization and forward sample collection from lesions perpendicular to the airway as well as with side collecting transbronchial biopsy tools in the wall of a bronchus parallel to the biopsy probe Aim is to evaluate in a swine model the feasibility and ability of the tools developed in the preceding aim to collect tissue samples with sufficient yield to enable standard and molecular pathology diagnosis and prediction of the biological behavior of malignant lesions PUBLIC HEALTH RELEVANCE Lung cancer is the most common cause of cancer death worldwide More than million people die annually and the year survival rates have improved only marginally in the last three decades While population based screening programs based on low dose computed tomography CT are likely to reduce the number of deaths due to lung cancer a significant challenge that remains is how to safely and accurately diagnose small spots nodules found on a screening CT Our project is to develop small biopsy probes with integrated real time image guidance The biopsy probes will be inserted into the biopsy channel of a standard bronchoscope and navigated to the lung spot using virtual bronchoscopy similar to a GPS guidance system The probe will use optical coherence tomography OCT to confirm the exact location of the spot to be sampled The principle of OCT is similar to ultrasound Instead of sound waves near infrared light is used to produce a high definition image similar to looking down a microscope Our OCT probe will be much smaller than an ultrasound probe It can detect blood vessels using the Doppler effect and analyze the chemical contents of the nodule using tissue autofluorescence imaging The procedure will be done under local anesthesia to the throat and conscious sedation These innovative imaging biopsy probes will be the first of its kind to allow the accurate biopsy of small lung nodules while minimizing complications such as bleeding and lung collapse It will advance the bronchoscopic diagnosis of small lung lesions