US-based company Monteris Medical has obtained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to test its NeuroBlate System in patients newly diagnosed with glioblastoma multiforme (GBM).
The NeuroBlate System has been developed as a type of MRI-guided laser interstitial thermal therapy (LITT) used by surgeons to destroy and coagulate soft tissue lesions in the brain.
It offers a 3D approach to monitor the ablation contours and provides real time imaging to aid a surgeon’s clinical decision matrix.
The NeuroBlate System uses diode laser energy delivered through a gas-cooled fiber-optic probe facilitating a safe targeting and selective ablation of soft tissue and lesions in the brain.
Following the IDE approval, the company is planning to conduct the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG).
Barrow Neurological Institute in Phoenix practicing neurosurgeon Kris Smith said: "Although complete tumor resection in GBM is associated with improved survival, traditional open surgery is not optimal for patients with difficult to access deep seated lesions, and it also carries an increased risk of damage to adjacent healthy tissue.
"Data from a preliminary first in human study evaluating laser thermotherapy to treat recurrent GBM demonstrated clinical potential and we expect ongoing research will help us better understand how patients with newly diagnosed GBM respond to this type of intervention."
The trial is designed as an open-label, prospective trial to assess the safety, feasibility and effectiveness of the NeuroBlate System used with the conventional radiation and chemotherapy in patients with newly diagnosed GBM.
The study is planning to enroll patients who cannot undergo complete surgical resection owing to location, shape or size of the tumour.