SBIR-STTR Award

We will develop a fluorescence image guided surgery (FIGS) system that delivers optimum, background-free performance without the need to turn off or lower room lighting. Fluorescence image-guided surgery (FIGS) is a rapidly evolving field with broad clinical applications, including more efficacious removal of tumors in real-time; however, ambient room lighting contaminates the fluorescence signal emitted from the patient during the surgical procedure. We are applying a new method called transient lighting that utilizes high-power - low duty cycle switched white LEDs for room and surgical field illumination allowing for timed fluorescence capture that is not affected by the room lights. As part of this project OnLume, Inc. will design and test a prototype system for surgical applications.

Public Health Relevance Statement:
Project Narrative Fluorescence image-guided surgery (FIGS) is a powerful technique with many applications, such as determining the extent of a tumor in real-time during surgery, but ambient lighting hinders the effectiveness of the technique and often requires the lights in the operating room to be turned off. We propose to develop and test an ergonomic wide field FIGS system that can operate in a well-lit operating room without compromising sensitivity. This will have a broad impact on public health by allowing for faster surgical procedure times, safer surgeries, and increased adoption of FIGS.

Project Terms:
abstracting; Address; Adoption; Affect; Aminolevulinic Acid; Animal Experimentation; animal imaging; Animal Model; Animals; base; Boxing; Cancer Model; cancer surgery; Clinical; clinical application; Collaborations; Collection; commercialization; Darkness; design; Detection; Development; Effectiveness; Environment; ergonomics; Excision; Eye; Fluorescein; Fluorescence; fluorescence imaging; fluorescence microscope; Fluorescent Probes; Frequencies; Goals; Gold; Guidelines; Human; Image; Image-Guided Surgery; Imagery; Imaging Device; imaging system; Imaging technology; in vivo; Laboratory Research; Light; Lighting; malignant breast neoplasm; Measurement; meetings; Methods; mouse model; Noise; Operating Rooms; Operative Surgical Procedures; Optics; Patients; Performance; Phase; Photons; Physiologic pulse; prototype; Public Health; Research; Research Institute; seal; Signal Transduction; software development; Speed; standard of care; System; Techniques; Testing; Time; Tissues; tumor; Validation; Work

This proposal aims to address the unmet clinical need for intraoperative assessment of blood and lymphatic vasculature to reduce the prevalence of two breast cancer-related morbidities: lymphedema and tissue necrosis. Current imaging systems are cumbersome, requiring ambient room lights to be turned off, have poor fluorescence sensitivity, or provide images that are difficult to interpret. OnLume will develop the clinical cart- based Asimov Imaging Platform to work in combination with the FDA-approved fluorescent dye, indocyanine green, that not only enables real-time image capture of small vessels with ambient lights on without degradation to image contrast, but also is easy for surgeons to use and interpret resulting in a platform that will be optimized to provide clinical value across multiple procedures in the breast cancer surgery workflow. More than 250,000 women a year undergo surgery for breast cancer in the United States. Conventionally, surgeons rely on white light reflectance as a guide to assessing vessel patency, which is extremely difficult to visualize. Lymphedema, an incurable disease associated with damage to lymphatic vessels, may occur in up to 40% of breast cancer survivors; associated symptoms include pain, heaviness and limitations in motility and associated costs range from $3000 to $16,000 per annum. Resection of lymph nodes that drain from the breast while sparing the lymphatic channels may decrease the risk of lymphedema. Some women who undergo mastectomy may choose breast reconstruction with a free flap surgery, where plastic surgeons reattach blood vessels between donor and recipient tissue sites to reconstruct a breast mound. Surgeons must assess vessel patency to decrease the risk of tissue necrosis and secondary operations. In 15-25% of cases, patients undergo secondary surgery to correct tissue necrosis, incurring costs that can exceed $14,000 per procedure. Our novel imaging system will be evaluated in a pilot study to measure the efficacy of the visualization of the blood and lymphatic architecture. This Phase II proposal has three specific aims: (1) complete development and integration of novel technology into a clinical transient lighting-enabled, wide-field fluorescence-guided surgery cart-based imaging platform, (2) demonstrate enhanced contrast of lymphatics for axillary reverse mapping (ARM), and (3) evaluate blood vessel patency in free flap breast reconstruction. Successful completion will result in a commercially available clinical wide-field FGS imaging system, providing critical intraoperative imaging that could enable breast surgeons and plastic surgeons to improve the health and quality of life for breast cancer survivors.

Public Health Relevance Statement:
Project Narrative This proposal aims to address the unmet clinical need for intraoperative assessment to reduce the risk of two breast cancer-related morbidities, lymphedema and tissue necrosis, by enabling breast surgeons to see these small lymphatic and blood vessels. OnLume’s Asimov Imaging Platform enables surgeons to perform fluorescence-guided surgery to avoid damaging these vessels and check to see how well they are repaired. This critical intraoperative imaging device could improve the health and quality of life for breast cancer survivors.

Project Terms:
Abdomen; Address; Anastomosis - action; Animals; Architecture; arm; associated symptom; Axilla; Axillary Lymph Node Dissection; Axillary lymph node group; base; Blood; Blood Vessels; Breast; Breast Cancer Patient; Breast Cancer survivor; Breast Cancer Treatment; Breast Oncology; breast surgery; Caliber; cancer surgery; cell motility; Clinical; clinical imaging; commercialization; Computer software; contrast enhanced; contrast imaging; cost; Cues; design; Detection; Development; Diagnosis; Disease; draining lymph node; Dyes; Excision; experience; Extravasation; Failure; FDA approved; Fluorescence; fluorescence-guided surgery; Fluorescent Dyes; Health; Image; Image-Guided Surgery; Imaging Device; Imaging Phantoms; imaging platform; imaging system; improved; In Vitro; in vivo; Indocyanine Green; Injections; Institution; Institutional Review Boards; Interruption; Isosulfan Blue; Light; Lighting; Lymph Node Mapping; Lymphatic; lymphatic drainage; lymphatic vasculature; lymphatic vessel; Lymphedema; malignant breast neoplasm; Mammaplasty; Maps; Mastectomy; Measurable; Measures; Methods; Morbidity - disease rate; Necrosis; new technology; Noise; novel; operation; Operative Surgical Procedures; Pain; Palpation; Patients; Performance; Perfusion; Phase; Pilot Projects; Plastic Surgeon; Postoperative Period; preservation; Prevalence; Procedures; Quality of life; real-time images; reconstruction; repaired; Research; Resolution; Risk; Sentinel Lymph Node Biopsy; Signal Transduction; Site; standard of care; Surgeon; Surgical Flaps; Surgical Oncologist; System; Techniques; Time; Tissues; Translating; United States; user friendly software; Visual; Visualization; Woman; Work