ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery
University of Illinois at Chicago
Summary
Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. The current golden standard for intraoperative glioma detection is fluorescence-guided surgery (FGS) using 5-ALA. In 5-ALA FGS the drug-induced fluorescence helps to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are routinely used to remove cancerous tissues, but so far, the analysis of the suction waste has not been used in near real-time tissue detection.
Description
A novel medical device (HIVEN®) detects 5-ALA-induced fluorescence from the surgical suction and gives sound feedback to the operating surgeon indicating tumor tissue and overcoming the challenges is the contemporary FGS methods. The 5-ALA (Gleolan, NX Development Corp) has been already FDA-approved since 2017 for fluorescence-guided resection of suspected WHO grade 3 or 4 gliomas. The HIVEN® device has been investigated in Europe during 33 surgeries and the MDR (EU) 2017/745 approval was granted on 09/2025.The device is commercially available in the EU starting from 09/2025. The CE mark is ap…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria:- * Patient admitted to neurosurgery department for surgical resection of a suspected grade 3 or 4 glioma with 5-ALA (cases) * Patient admitted to neurosurgery department for surgical resection of a primary of secondary brain tumor with no 5-ALA (controls) * Patients aged 18 years old or older (all patients) * Informed consent obtained (all patients) Exclusion Criteria: * Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled. * The participants are not randomized. Randomization is not conducted as the number of eligib…
Interventions
- DeviceHIVEN Medical Device
A medical device (HIVEN®) detects 5-ALA-induced fluorescence from the surgical suction and gives sound feedback to the operating surgeon indicating tumor tissue and overcoming the challenges is the contemporary FGS methods. The device is used for detecting fluorescence of flowing tissues within a transparent tube and providing auditory feedback of tissue fluorescence for neurosurgeons. There is no patient contact intended with this device.
Location
- University of Illinois at ChicagoChicago, Illinois