Researchers just concluded their first in-human study of the NeuroBlate Thermal Therapy System, a new MRI-guided, laser-based technology that provides a safe and minimally invasive alternative for treating recurrent glioblastoma, a malignant type of brain tumor.
The NeuroBlate Thermal Therapy System offers surgeons a safe, minimally invasive alternative to treating glioblastoma.
In layman’s terms, NeuroBlate is a technology that “cooks” brain tumors in order to destroy them. Due to the positive results of the study, NeuroBlate recently received FDA clearance for use in human patients.
How NeuroBlate works
The patient is placed under general anesthesia and has a small hole drilled into their skull. A thin, high-intensity laser probe is then inserted through the hole and deep into the brain, to the location of the tumor. Next, the tip of the probe emits laser energy sideways, which coagulates and destroys brain tumor tissue in one direction while simultaneously cooling the area to immediately remove the heat and protect normal tissue in neighboring areas.
The laser generates heat up to 160ºF, more than enough to coagulate and destroy the cancer cells. Each burst of laser energy lasts somewhere between 30 seconds and a few minutes. Tumor destruction is monitored by the surgeon on a computer screen at a remote location. The procedure is planned and controlled from this station, allowing the surgeon to steer the direction of the heat directly onto the tumor tissue. MRI thermometry measures temperature in and around the tumor, which helps the surgeon monitor the procedure in real time.
Once the surgery is complete, the patient stays in the hospital for a day or two to recover, about half the recovery time when compared to hospitalization following conventional surgery.
“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,” said Dr. Andrew Sloan, lead author of the study on this technology and Director of Brain Tumor and Neuro-Oncology Center at University Hospitals Case Medical Center and Case Comprehensive Cancer Center. “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.”
Phase I clinical trial
The study that Dr. Sloan and the rest of his team worked on is considered a Phase I clinical trial. Its purpose was to investigate the safety and performance of the laser probe system. In order to do this study, the group first had to get approval from the FDA, which gave the system's developer Monteris Medical and the Case Comprehensive Cancer Center, an investigatory device exemption to study the system in patients with glioblastoma.
Following the study, the group published a report in the Journal of Neurosurgery describing their results. They treated a total of 10 patients using NeuroBlate. The group had a median age of 55, and each individual had a tumor diagnosed as “high risk” for open surgical resection because of their location; specifically, they were too close to vital areas of the brain or were otherwise difficult to access via conventional surgery.
“Overall the NeuroBlate procedure was well-tolerated,” said Dr. Sloan. “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 ½ months, better than expected for patients with such advanced disease.”
The study’s principal investigator Gene Barnett, MD, Director of the Brain Tumor and Neuro-Oncology Center at Cleveland Clinic and Case Comprehensive Cancer Center, reflected on the study, saying, “Previous attempts using less invasive approaches such as brachytherapy and stereotactic radiosurgery have proven ineffective in recent meta-analysis and randomized trials”. He adds, “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.”
Accessing the NeuroBlate paper
Dr. Sloan and Dr. Barnett worked with colleagues from University Hospitals, Cleveland Clinic, Cleveland Clinic Florida, University of Manitoba, and Case Western Reserve University.
Access the study online via the Journal of Neurosurgery website.
Story via: University Hospitals Case Medical Center
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