SBIR Phase I: Gamma Camera Design Studies for Intraoperative Imaging

M3d, Inc., Ann Arbor MI

Investigators

Abstract

The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel capital medical imaging system enabling new 3-Dimensional (3D) image capture and analysis for real-time guidance of surgical cancer biopsy and resection procedures. The system aims to significantly improve radio-guided surgical procedures with a novel means of rapidly and accurately detecting gamma-ray emitting radiotracers used to identify the location of lymph nodes (LN) and drainage of lymphatic fluids from tumors to be biopsied for determination of whether the primary cancers have spread. The overall benefits include shorter durations and more accurate sentinel lymph node biopsy procedures. If successful, the system represents a new standard of care versus current non-imaging technologies including Geiger pens, and targets a $3B initial opportunity for an initial target market of skin cancer accounting for 1.5M annual new US cases per year. The system provides potential to impact other similar performed procedures used to assess suspected breast, pelvic and head and neck cancers. This Small Business Innovation Research (SBIR) Phase I project will develop the company’s proprietary gamma ray radiation imager suitable for use for image guided tumor diagnostics. The project will include individual and grouped characterization of the design parameters and their effect on diagnostic sensitivity for acquiring images, and whether convolutional mathematical approaches to iterative image reconstruction can reduce the time needed to produce the final image of a medical radiotracer. The final objective is to determine the optimal collimation design parameters and image reconstruction techniques, followed by validation. The end result will be to demonstrate proof-of-principle that the novel gamma imager can produce fast, high-resolution images adequate for radio-guided lymph node biopsy and resection surgeries. The result will demonstrate superiority to current gamma camera approaches that utilize parallel-hole, pinhole, or coded-aperture collimation allowing them to produce either 1) low-resolution images rapidly or 2) high-resolution images slowly, but not the fast and high-resolution imaging needed for surgical guidance. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.