Near infrared autofluorescence (NIRAF) can aid in identifying parathyroid glands (PGs) during thyroidectomies. Additionally, surgeons use indocyanine green (ICG) to evaluate PG perfusion. However, there is spectral overlap between PGs and ICG making parathyroid identification challenging after ICG injection. ICG dose adjustment may be needed for quantitative tissue perfusion assessment without interfering with PG NIRAF detection. This work investigated the utility of probe-based detection to determine PG vascularity using ICG doses of 0.25 and 1.25 mg. A mathematical model was also developed to determine the ICG dosage threshold for concurrent vascularity assessment and NIRAF detection of PGs.
Several studies have already demonstrated that near infrared autofluorescence (NIRAF) detection can be reliably used to detect parathyroid glands (PGs) in adults. However, its scope remains unexplored in the pediatric population, who are more prone to accidental PG damage during neck surgeries. Our preliminary findings obtained from pediatric patients who underwent thyroidectomies, indicate a PG detection rate of 94.4% using NIRAF detection with a fiber-optic probe-based approach. Due to the complexities associated with surgeries performed through tiny neck incisions in the pediatric population, the fiber-optic probe-based NIRAF detection can be valuable for real-time label-free PG identification during pediatric neck surgeries.
Identifying parathyroid glands can be challenging for surgeons during head and neck operations. For the surgeon, it becomes essential to preserve healthy parathyroid glands, while successfully removing diseased parathyroid glands. This study presents PTeye – a commercial fiber probe-based device that was designed for intraoperative parathyroid identification by detecting near infrared autofluorescence. The results of this study demonstrate that PTeye had 95% accuracy in identifying parathyroid glands in 78 patients. The device had an overall detection rate of 97% for healthy and diseased parathyroid glands. PTeye could also quantify parathyroid vascularity in real-time by using indocyanine green during neck surgeries.
The process of translating lab-built innovations into viable tools for clinical applications is complex and costly. Clearing the regulatory processes is the pivotal step that eventually enables these devices to be implemented for the intended clinical applications. Unfortunately this task could be challenging and time-consuming for unprepared academics aiming to translate their inventions/discoveries from bench to bedside. Therefore there is a vital need to educate researchers on adopting the best approach when dealing with regulatory submissions to ensure smoother translation of their respective technologies.
To understand the bench to bedside pathway more clearly, we will utilize the example of the first-ever discovery of near infrared autofluorescence in parathyroid glands at Vanderbilt University. Subsequently a lab-built system was designed for label-free intraoperative parathyroid identification during thyroid and parathyroid surgeries, which was tested across 162 patients with high accuracy. Subsequently Vanderbilt University partnered with AiBiomed (Santa Barbara, California) to develop a clinical prototype called ‘PTeye’ that was user-friendly for surgeons and ready-to-use in operation rooms. The ‘PTeye’ was then evaluated across 81 patients in a single-blinded, multi-centric study that yielded 96% accuracy. Relying on this data, Vanderbilt University and AiBiomed initiated the ‘de novo’ application process with the Food and Drug Administration (FDA) for regulatory clearance of the ‘PTeye’. The ‘de novo’ approach was selected since the instrument design and intended use of ‘PTeye’ did not resemble that of any pre-existing medical devices. Following a successful review, the FDA eventually granted permission to market ‘PTeye’ as an adjunct intraoperative tool for label-free parathyroid identification.
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