Minimally Invasive, MRI-Guided Laser Treatment For Glioblastoma Found to be Safe in Phase I Trial

In a recently published study, neurosurgeons found that a new MRI-guided laser treatment used for the first time in a human study called NeuroBlate? Thermal Therapy System (formerly known as AutoLITT?) a from of Laser Interstitial Thermal Therapy or LITT, offers them a new, safe and minimally invasive procedure for treating recurrent glioblastoma (GBM), a malignant type of brain tumor.

In the article, published in the April 5, 2013 online edition of the Journal of Neurosurgery, the authors explain that the primary goal of the study was to demonstrate the safety and feasibility of the technique and that superiority of this procedure over biopsy alone in terms of outcome is likely, and thus, represents a promising potential alteration in the treatment paradigm for patients with GBM.

Despite significant efforts and recent progress, the prognosis for patients with GBM remains dismal. Today, much research focuses on treatment options after surgery. This strategy can be optimized in patients with low tumor burden or for patients whose surgical intervention resulted in gross-total or extensive resection.

For more that 20 years LITT has been successfully used in the treatment of patients with cancer. However, much of these treatments focuses on areas such as metastatic disease in the liver and prostate (including benign prostatic hypertrophy or BPH). One of the primary reasons is that in organs such as the liver, the borders of treatment can extend beyond the lesion. Damage to surrounding tissues beyond the lesions is in most cases somewhat tolerable. However, in contrast with metastatic organ disease, the treatment of brain tumor has to be highly conformal and focused because targeting the therapy outside of the tumor can result in unacceptable neurological morbidities and cerebrovascular sequelae. On the other hand, if the treatment volume is inadequate, the treatment may result in lack of efficacy.

Minimally Invasive
‘NeuroBlate’ is a device that “cooks” brain tumors in a controlled fashion to destroy them. It uses a minimally invasive, MRI-guided laser system to coagulate, or heat and kill, brain tumors. The procedure is conducted in an MRI machine, enabling surgeons to plan, steer and see in real-time the device, the heat map of the area treated by the laser and the tumor tissue that has been coagulated.

“This technology is unique in that it allows the surgeon not only to precisely control where the treatment is delivered, but the ability to visualize the actual effect on the tissue as it is happening,” noted lead author Andrew Sloan, MD, director of Brain Tumor and Neuro-Oncology Center at University Hospitals (UH) Case Medical Center and Case Comprehensive Cancer Center, who also served as co-Principal Investigator. “This enables the surgeon to adjust the treatment continuously as it is delivered, which increases precision in treating the cancer and avoiding surrounding healthy brain tissue.”

The Phase I study investigated the safety and performance of NeuroBlate, a specially-designed laser probe system. The FDA gave the system’s developer Monteris Medical and the Case Comprehensive Cancer Center, (comprised of the UH Case Medical Center, Cleveland Clinic, and Case Western Reserve University School of Medicine), an investigatory device exemption (IDE) to study the system in patients with GBMs. The device has recently been cleared by the FDA due, in part, to the results of the study.

The paper describes the treatment of the first 10 patients with this technology. These patients, who had a median age of 55, had tumors which were diagnosed to be inoperable or “high risk” for open surgical resection because of their location close to vital areas in the brain, or difficult to access with conventional surgery.

Well-tolerated
“Overall the NeuroBlate procedure was well-tolerated,” Sloan said. “All 10 patients were alert and responsive within one to two hours post-operatively and nine out of the 10 patients were ambulatory within hours. Response and survival was also nearly 10 ? months, better than expected for patients with such advanced disease.”

Commenting on the results, Principal Investigator Gene Barnett, MD, director of the Brain Tumor and Neuro-Oncology Center at Cleveland Clinic and Case Comprehensive Cancer Center, said: “Previous attempts using less invasive approaches such as brachytherapy and stereotactic radiosurgery have proven ineffective in recent meta-analysis and randomized trials. However, unlike therapies using ionizing radiation, NeuroBlate therapy results in tumor death at the time of the procedure. A larger national study will be developed, as a result of this initial success.”

For more information:
Sloan AE, Ahluwalia MS, Valerio-Pascua J, Manjila S, Torchia MG, Jones SE, et al. Results of the NeuroBlate System. Journal of Neurosurgery; Published online April 5, 2013; DOI: 10.3171/2013.1.JNS1291.-in-humans Phase I clinical trial for recurrent glioblastoma.
-Elder JB, Chiocca EA. Editorial: Glioblastoma multiforme and laser interstitial thermal therapy.
Journal of Neurosurgery; Published online April 5, 2013; DOI: 10.3171/2012.9.JNS121563.

Disclosure: Sloan and Barnett are paid consultants for Monteris Medical and members of the company’s Medical Advisory Board.

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