Intraoperative 5-aminolevulinic acid fluorescence-guided aspirate tissue monitoring in high-grade glioma surgery: The first-in-human study on clinical performance and safety.

Introduction: The resection of high-grade gliomas (HGGs) is limited by diffuse tumor growth and the need to avoid the eloquent tracts. Although fluorescence-guided surgery 5-ALA administration can enhance tumor-resection rates, its visual detection capability may be hindered by tissue obstructions, bleeding, and attenuation of fluorescence by ambient light. To address the limitations of visual fluorescence detection, we investigated the usefulness of an aspirate tissue-monitoring (ATM) device, which provides near-real-time auditory feedback on fluorescence from suction waste. Materials and Methods: Resections of HGGs were recorded, and data were collected using an ATM. Data were collected from 20 patients for performance analysis in an observational study, and an interventional trial validated clinical applicability with 8 patients who underwent resection with the ATM connected to an ultrasonic aspirator. An expert panel defined tissue fluorescence visibility from the videos. Results: The ATM detected fluorescence 483% more frequently than visual inspection and for 613% longer. In comparison with the visual assessments, the specificity and sensitivity of the ATM for fluorescence were 100% and 83%, respectively. In histopathological assessments, all the fluorescent areas contained HGGs. The expert panel showed good agreement (average overall agreement rate = 96.7%) for the inference that the ATM is a safe technique that adds value to tissue-mapping techniques. Discussion and Conclusion: This first-in-human clinical trial evaluated the ATM as an adjunct to visual detection of 5-ALA fluorescence. The ATM provided supplementary fluorescence information during surgery, and its performance under while-light illumination was at least as good as visual analysis under blue-light.