Via: Monteris Medical
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.
Read More: https://www.monteris.com/press-releases/monteris-medical-announces-first-patient-enrolled-in-remaster-clinical-study-on-neuroblate-system-for-metastatic-brain-tumor-patients/
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