The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) to Monteris Medical to evaluate the NeuroBlate system in patients newly diagnosed with glioblastoma multiforme. With this approval, Monteris will initiate the Feasibility Study on Laser Interstitial Thermal Ablation for the Treatment of Newly Diagnosed GBM (FLAG), an open-label, prospective study that will be conducted in five sites in the USA.
Monteris previously conducted an IDE approved study to evaluate the NeuroBlate System in patients with recurrent glioblastoma multiforme and recently announced an additional IDE approval to evaluate the system in patients with medically refractory epilepsy.
“Glioblastoma multiforme continues to be one of the most lethal cancers, and new approaches for managing this disease are urgently needed,” says Eric C Leuthardt, professor of Neurological Surgery at Barnes-Jewish Hospital and director of the Center for Innovation in Neuroscience and Technology, and the Brain Laser Center at Washington University School of Medicine. “Preliminary data suggest that laser interstitial thermal ablation treatment (LITT) may have potential in newly diagnosed glioblastoma multiforme cases, and the FLAG study will further our understanding of its potential in improving the care and outcomes for patients. Additionally, we anticipate LITT’s minimally invasive approach may have benefits over open craniotomy for this population.”
“Although complete tumour resection in glioblastoma multiforme 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,” says Kris Smith, practicing neurosurgeon at the Barrow Neurological Institute in Phoenix, USA. “Data from a preliminary first in human study evaluating laser thermotherapy to treat recurrent glioblastoma multiforme demonstrated clinical potential and we expect ongoing research will help us better understand how patients with newly-diagnosed glioblastoma multiforme respond to this type of intervention.”
FLAG is designed to characterise the safety, feasibility and effectiveness of the NeuroBlate system in combination with standard of care radiation and chemotherapy in patients with newly-diagnosed glioblastoma multiforme. The study will enrol participants for whom a complete surgical resection is unsafe due to location, shape or size of the tumour. Overall survival, progression-free survival, patient quality of life and healthcare utilisation will be assessed during the trial in 30 patients followed for up to 12 months after the procedure and subsequent radiation and chemotherapy. According to a company release, Monteris Medical expects to initiate FLAG in the fourth quarter of 2016.