Optical Insights, LLC proposes to combine confocal microscopy with magnetic resonance imaging (MRI) to produce a versatile and clinically viable catheter-based system for in-vivo histopathologic evaluation of tissue. Microscopic imaging has long been employed to evaluate biopsy tissue samples at the cellular level. In many applications, however, the biopsy process is fraught with problems including improper selection of tissue for removal and damage to the sample during removal. The catheter- based system proposed here would bring the confocal microscope to the patient allowing microscopic evaluation of the cells while inside the body, thus alleviating the problems associated with tissue biopsy. Since this is a high magnification, small field-of-view system, a guidance mechanism is required to properly position the catheter for tissue evaluation. MRI, which is one of the most sensitive and versatile imaging modalities for visualizing both normal anatomy and pathology, represents a low magnification, wide field-of-view imaging system, which could be used for this purpose. The innovative aspects of this proposal deal with the design and fabrication of the catheter components for MRI compatibility and minimal invasion. The successful marriage of these microscopic and macroscopic imaging modalities would represent a significant advance for in-situ diagnosis of pathologic lesions and tumors.
Considering that hundreds of thousands of biopsies are performed every year, this system would have a significant impact by enhancing diagnostic capabilities, leading to earlier detection of pathology. Novel technologies which demonstrate better performance and minimize patient discomfort will see immediate acceptance, especially if they have applications to cancer. During the Phase I and Phase II efforts, a serious effort will be undertaken to form alliances with endoscopy companies for the subsequent Phase III effort when FDA approval for the device will be sought. A parallel effort will be made with MRI companies, such as General Electric Corp., to incorporate the real-time tracking capabilities into clinical MRI systems.
