Monteris Medical Announces First Patient Enrolled in REMASTer Clinical Study on NeuroBlate® System for Metastatic Brain Tumor Patients
The randomized controlled multicenter study is the first-of-its kind to investigate LITT benefits in radiographically recurrent brain metastasis patients
MINNETONKA, Minn. – Sept. 7, 2022 – Monteris Medical announced today that the first patient has been enrolled in its REMASTer (Recurrent Brain Metastases After Stereotactic Radiosurgery [SRS] Trial) clinical trial. This randomized controlled study is designed to investigate laser interstitial thermal therapy (LITT) using the NeuroBlate System as an early intervention for radiographically progressive brain metastases and to provide Level I evidence to guide treatment for this complex patient population.
Treatment of recurrent brain metastases is challenging as no standardized care currently exists within the clinical community for patients with disease progression following SRS. This is primarily attributed to the uncertainty of the underlying cause being either recurrence or radiation necrosis. In recent years, LITT has proved to be an effective tool for both causes of progression after SRS and can be performed during the same procedure as needle biopsy. Recent published studies suggest that LITT plus SRS may be superior to LITT alone or repeat SRS alone for treatment of biopsy-proven brain metastasis recurrence after SRS failure, even after controlling for variables known to predict progression. Recent literature also has revealed LITT to be effective for the treatment of radiation necrosis, with a superior time to steroid independence compared to medical management alone.
The REMASTer trial is designed to determine the superior treatment algorithm for both the recurrent tumor and radiation necrosis populations. The study will enroll 154 patients at up to 12 sites. Primary endpoints for the study include time to local intracranial progression or death and time to steroid cessation. Additional endpoints include comparison of treatment approaches with respect to overall survival, quality of life, and cognitive changes over time.
“The REMASTer trial will be vital in providing Level I evidence that establishes a critically needed standard of care in patients who have radiographically progressive metastatic disease, be it radiation necrosis or true disease recurrence,” said Dr. Peter Fecci, director of the Brain Tumor Immunotherapy Program and the Center for Brain and Spine Metastasis at Duke University School of Medicine in Durham, N.C. and REMASTer principal investigator. “Rapidly establishing steroid independence in the radiation necrosis population in the era of immunotherapy is crucial, as is optimizing freedom from local progression in patients with truly recurrent brain metastatic disease. This study will help to solidify the role for LITT in both scenarios.”
It is estimated that up to 300,000 patients in the United States are diagnosed annually with metastatic brain tumors. The incidence of metastatic brain tumors has risen in recent years due to patients living longer with systemic cancers as a result of treatment advances, increased imaging procedures and early detection, and improvements in imaging technology. Metastatic tumor progression and radiation necrosis are therefore increasing in prevalence as well, necessitating the need for standard of care approaches to patient treatment.
“While the data supporting the use of LITT in radiation necrosis and recurrent metastatic disease is already strong enough to warrant inclusion in National Comprehensive Cancer Network® guidelines, evidence is lacking to advise the best time for LITT in the treatment algorithm for patients with radiographic progression,” said Jennifer Englund, vice president of clinical and regulatory affairs of Monteris. “We believe the study Dr. Fecci has designed is poised to deliver meaningful results that will standardize treatment for this growing population of patients.”
Information about the REMASTer study can be found here: https://clinicaltrials.gov/ct2/show/NCT05124912.
About Monteris and the NeuroBlate System
Monteris Medical is a privately held company that develops and markets innovative MR-guided ablation systems to perform minimally invasive, robotically controlled brain surgery, commonly referred to as laser ablation, LITT (Laser Interstitial Thermal Therapy) or SLA (Stereotactic Laser Ablation). The Monteris NeuroBlate System is the only minimally invasive system that enables a robotic interface for the precise and safe delivery of laser energy. The Monteris Medical NeuroBlate System is a neurosurgical tool and is intended for ablating intracranial soft tissue, including brain structures such as brain tumors, radiation necrosis, and epileptogenic foci (as identified by non-invasive and invasive neurodiagnostic testing, including imaging). For more information, visit monteris.com.
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