Study of Aspirate Tissue Monitoring During Surgery for Suspected High-Grade Gliomas to Improve Tumor Removal and Outcomes

What this Trial Is About

Gliomas are tumors that can occur at any age and represent the most common malignant primary central nervous system tumors in developed countries. These tumors are often aggressive and typically treated with surgical removal followed by chemoradiation. Complete removal of gliomas is difficult due to their diffuse growth and closeness to important brain areas. Surgeons use a drug called 5-aminolevulinic acid 5-ALA to make tumor cells fluoresce during surgery, which helps identify tumor tissue. However, some tumor cells may be missed because of weak fluorescence or visual barriers, leading to tumor recurrence and additional surgeries. This study evaluates a new device called the aspirate tissue monitor ATM that detects cancerous tissue in the suction waste during surgery for suspected high-grade gliomas. The ATM provides near real-time audible feedback to the surgeon when tumor-related fluorescence is detected in the aspirated tissue. Patients prescribed oral 5-ALA before surgery are divided into two groups one operated with ATM assistance and the other with standard fluorescence-guided surgery without ATM. Both groups may use other common techniques like MRI guidance and neuronavigation. Participants will be monitored over four years to assess outcomes including the extent of tumor removal, overall and progression-free survival, performance status, number of reoperations, blood loss, and operation duration. Data from 50 patients using ATM will be compared to 50 matched controls from clinical records. Patients will consent to data collection, and their surgical and health status will be evaluated regularly to understand if ATM improves surgery effectiveness and patient outcomes.

Feasibility of Aspirate Tissue Monitoring in Neuro-oncological Surgery