INVENIO IMAGING INC — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant Surgical resection is the cornerstone treatment for the majority of the primary brain tumors and brain metastases diagnosed each year in the US Extent of resection is an important prognostic factor as most tumor recurrence is in or near the resection cavity Unfortunately safely maximizing the extent of resection remains a challenge in part due to the difficulty of differentiating tumor from normal brain tissue Consequently suboptimal surgical outcomes are common for brain tumor patients A recent study showed that among patients with safely resectable tumors complete resection was achieved in only of patients Stimulated Raman Scattering SRS microscopy co developed by the technical Co PI Dr Freudiger allows label free imaging of biological tissues based on the intrinsic vibrational spectroscopy of their molecular components Science In collaboration with clinical Co PI Dr Orringer we recently demonstrated SRS microscopy enables rapid histology with image quality and diagnostic accuracy comparable to gold standard Handamp E staining but without the time delay caused by tissue sectioning and dye staining Science Translational Medicine Compared to other techniques under investigation SRS produces the best image quality and consequently the highest sensitivity and specificity for detecting tumor infiltration The overall goal for this Phase grant is to develop the first FDA cleared clinical SRS instrument based on the validated prototype incorporating our custom fiber laser This innovation will lead to the introduction of a novel technology to improve the safety and accuracy of brain tumor surgery Specifically we will establish quality systems for design and assembly according to federal regulations CRF We will then design the clinical SRS instrument to overcome the limitations of the prototype i e improve the imaging speed for multi color mosaic imaging automate the sample loading scheme modify the form factor include design controls for compliance with electrical and laser safety standards develop a simple graphical user interface and develop a sterile consumable We will work with an independent test laboratory to demonstrate safety according to the IEC standard for medical devices and the IEC standard for laser products The clinical Co PI will validate the effectiveness by performing a blind read study comparing SRS imaging to the gold standard Handamp E histopathology Biocompatibility of the consumable will be demonstrated by compliance with ISO As the final goal we will work with an experienced regulatory consultant to obtain FDA clearance for the product PUBLIC HEALTH RELEVANCE Brain surgery is the cornerstone for the treatment of most of primary brain tumors and many of the brain metastases diagnosed in the US each year Survival and quality of life depend strongly on the extent of tumor resection but brain surgeons tend to err on the side of lesser resection to avoid neurologic deficits leaving some tumor behind because tumor is not readily distinguished from uninvolved tissue by the bare eye This proposal aims to develop a novel microscope and an associated consumable that together will allow brain surgeons to accurately access the completeness of resection in real time during brain surgery and if successful will improve survival and quality of life for patient with this devastating disease