ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery

What this Trial Is About

Gliomas are tumors that can affect people of all ages and represent the most common malignant primary brain tumors in developed countries. These tumors are often aggressive, and treatment typically includes surgery and chemoradiation. However, complete removal of gliomas is difficult due to their diffuse growth and proximity to critical brain areas. Current standard detection during surgery uses fluorescence-guided surgery (FGS) with 5-ALA, which helps surgeons see tumor cells, but some tumor cells may be missed due to visual challenges or weak fluorescence, leading to recurrence and further surgeries. The study evaluates a new device called HIVEN4, which detects 5-ALA-induced fluorescence from surgical suction waste and provides sound feedback to surgeons during brain tumor surgery. This device aims to improve tumor detection beyond current FGS methods by analyzing the suctioned tissue in near real-time. The 5-ALA drug is already FDA-approved for guiding surgery in suspected high-grade gliomas. HIVEN4 has been tested in Europe and received regulatory approval there, and this study will demonstrate its feasibility and benefit-risk profile as part of the FDA approval process. Participants undergoing surgery for suspected grade 3 or 4 gliomas or other brain tumors will have HIVEN4 used during their operation. Neurosurgeons and surgical nurses will assess the device’s usability, safety, and performance based on surgery videos and user feedback. Researchers will measure how well the device increases tumor fluorescence detection during surgery and evaluate its safety compared to standard visual guidance. The study involves monitoring during surgery and collecting user questionnaires, with participation lasting through the surgical procedure.

Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery