Abstract
The inability to identify microscopic tumors and assess surgical margins in real-time during oncologic surgery leads to incomplete tumor removal, increases the chances of tumor recurrence, and necessitates costly repeat surgery. To overcome these challenges, we have developed a wearable goggle augmented imaging and navigation system (GAINS) that can provide accurate intraoperative visualization of tumors and sentinel lymph nodes in real-time without disrupting normal surgical workflow. GAINS projects both near-infrared fluorescence from tumors and the natural color images of tissue onto a head-mounted display without latency. Aided by tumor-targeted contrast agents, the system detected tumors in subcutaneous and metastatic mouse models with high accuracy (sensitivity = 100%, specificity = 98% ± 5% standard deviation). Human pilot studies in breast cancer and melanoma patients using a near-infrared dye show that the GAINS detected sentinel lymph nodes with 100% sensitivity. Clinical use of the GAINS to guide tumor resection and sentinel lymph node mapping promises to improve surgical outcomes, reduce rates of repeat surgery, and improve the accuracy of cancer staging.
Highlights
Surgical resection is the standard of care for many solid tumors such as breast cancer and melanoma, and sentinel lymph node (SLN) mapping is used for cancer staging[1]
We have developed a new wearable goggle aided imaging and navigation system (GAINS) and evaluated the accuracy of using the well-characterized system for real-time intraoperative tumor visualization and image-guided tumor resection in small animals, as well as SLN mapping (SLNM) in human breast cancer and melanoma patients
The processing unit generates co-registered composite color-fluorescence images, which are displayed in real-time via a lightweight and high-resolution head-mounted displays (HMDs) unit
Summary
Surgical resection is the standard of care for many solid tumors such as breast cancer and melanoma, and sentinel lymph node (SLN) mapping is used for cancer staging[1]. Several NIR-FIGS systems have been developed, and successfully used for intraoperative tumor imaging and SLN mapping (SLNM), including FLARE24, Fluobeam[25], SPY26, and Hamamatsu PDE27 Each of these systems have some limitations, including the use of bulky hardware, potentially disruptive information display on a remote monitor, mismatch between the system’s and surgeon’s field of view (FOV), and require support from other workers to control the device. The primary goal of this study is to test the hypothesis that simultaneous, sensitive detection of color and NIR fluorescence information, fast image processing and image output via an HMD would allow non-disruptive access to accurately co-registered color-NIR images for real-time image guidance in oncologic surgery Toward this goal, we have developed a new wearable goggle aided imaging and navigation system (GAINS) and evaluated the accuracy of using the well-characterized system for real-time intraoperative tumor visualization and image-guided tumor resection in small animals, as well as SLNM in human breast cancer and melanoma patients
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