Details

Project TitleA Low-cost Loupe-based Intraoperative Fluorescence Imaging Device for the Guidance of Brain Tumor Surgery
Track Code2156
Short DescriptionA malignant brain tumor is a deadly and aggressive disease, significantly impacting quality of life. Surgical tumor resection is the main form of intervention and the extent of tumor removal is direc
AbstractA malignant brain tumor is a deadly and aggressive disease, significantly impacting quality of life. Surgical tumor resection is the main form of intervention and the extent of tumor removal is directly related to survival. A limiting factor for resection, however, is the surgeon's ability to differentiate the tumor from surrounding healthy tissue. Multiple imaging solutions (e.g., MRI, CT) have been explored for intraoperative guidance of resection, although incorporating these large and costly imaging modalities can significantly interfere with the surgical workflow. The use of real-time wide-field optical imaging techniques with a fluorescent contrast agent is more suited to the intraoperative environment and has shown significantly higher tumor resection rates than traditional surgeries. The technique is safe and simple: after intravenous injection of a fluorescence dye (e.g., fluorescein) an operative microscope equipped with a dedicated filter is used to enhance the visibility of fluorescing tumor tissue. Wide acceptance and use of the operative fluorescence microscope technique, however, has been limited by some challenging issues: (1) the microscope is very expensive; (2) the large size of the microscope presents challenges in small surgical suites and hinders portability; and (3) many neurosurgeons prefer to do much of the resection using wearable surgical eye loupes rather than using a large operative microscope. To overcome these limitations, this study will research a novel, low-cost, wearable, loupe-based, fluorescence imaging technique for easy and accurate identification of tumor margins during surgery, with the ultimate goal of reducing positive tumor margin rates and subsequent costly re-excision surgeries. Compact LEDs and a small CMOS camera with dedicated optical filters will be optically integrated into different functional modules of the wearable device for florescence excitation and detection. These lightweight, compact, and inexpensive modules will be mechanically assembled and attached to the surgical loupes (eyepiece) to form an all-in-one wearable device allowing for realtime ocular observation and video recording of fluorescence and color images during surgery. This device will first be constructed, optimized, and calibrated using tumor-simulating phantoms to ensure appropriate operation and sufficient accuracy (Aim 1). It will then be prospectively tested in the clinical setting and compared to the large operative microscope for intraoperative identification of brain tumor margins (Aim 2). An FDA-approved fluorescence dye (i.e., fluorescein) will be used to facilitate easy clinical translation of the novel technique. Histopathological analysis on biopsied samples at the tumor margin and postoperative contrast-enhanced MRI will be used as the 'gold standard' for comparison. The outcomes from this study will be a low-cost, wearable, easy-to-use, loupe-based, all-in-one fluorescence imaging technique, which can achieve the same level of accuracy as the large expensive operative microscope for intraoperative identification of surgical tumor margins. Following this pilot study, a large population study (e.g., R01) will be developed, and future randomized clinical trials will be proposed to determine the impact of fluorescein-guided brain tumor resection on survival.
 
Tagsbrain tumor surgery; surgical ergonomics; intraoperative fluorescence; cancer; hands-free wearable magnifying eye-loupe;
 
Posted DateJul 24, 2017 3:17 PM

Key Advantages

  • May improve the identification of complex tumor margins during surgery
  • May provide for superior surgical ergonomics; greater range of movement, less obstruction, smaller size, easier operation, wearable
  • May reduce cost up to 200%

Market Opportunities

Nearly 700,000 people in the US are currently living with a primary brain tumor. Brain tumor patients have the highest per-patient initial cost of care for any cancer group, with an annualized mean net cost of care well over $100,000. Surgical resection is the standard therapy for patients with early stage tumors, and more than half of all cancer patients undergo surgery. The technical ability of the surgeon to obtain clear surgical margins during surgery remains crucial to patient survival, and current resection techniques are largely based on subjective and subtle changes associated with tissue distortion. Imprecise techniques have led to large error rates and repeat surgeries. Accordingly, a real-time identification method with enhanced detection of tumor margins  is vital to treatment and prevention of brain tumors. Multiple imaging solutions (i.e. MRI and CT) have been implemented for tumor identification, however these modalities are large, costly and can significantly interfere with workflow. 


Technology Solution

IR 2156 developed a hands-free, wearable, magnifying eye-loupe-based imaging device, which uses fluorescence imaging to identify tumor margins. In contrast to currently available clinical-grade operative microscope systems that require surgeons to alternate between the surgical site and monitor, this device incorporates real-time ocular observation and video recording, allowing direct visualization of the surgical site. Other advantages include superior fluorescence excitation, specificity, convenience, economy of cost, space and technical time. Another major advantage of this device is that it also has the potential to be incorporated in other surgical settings beyond tumor resection surgeries. 


Commercialization Status

Patent filed

Available Fields of Use

  • Medical Devices
  • Neurosurgery 
  • Oncology

Inventors

Yu, Guoqing; Pittman, Thomas; Huang, Chong

Patent Number(s)

patent pending

UK OTC Contact

Eric Castlen, Associate Director, Office of Technology Commercialization

A141 ASTeCC Building, Lexington, KY 40506-0286

(859) 257-8211    eric.castlen@uky.edu

Files

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Market Assessment None Download