MR-Guided Laser Therapy of Brain Lesions Meets Safety Measures for Brain Cancer

Results from a phase 1-2 clinical study (NCT05296122)¹ showed that safety and feasibility measures among patients with primary and recurrent glioblastoma and grade 4 astrocytoma could be met using ClearPoint Prism Neuro Laser Therapy and Transberg laser applications MR-guided laser thermal ablation of brain lesions.²

ClearPoint Prism technology will be on display at the 75^th Annual Congress of Neurological Surgeons in Los Angeles from October 13 to 15.²

What Were the Primary and Secondary End Points?

The single arm clinical study ran from May 12, 2022, to October 30, 2024, and had 14 patients. The median ablation time was 6.5 minutes. There were no device-related events or complications reported in the initial results. The primary endpoint was the number and severity of adverse events (AEs) related to the Tranberg Laser applicator when used ion MR-guided laser thermal ablation of brain lesions. The secondary end point was the number and severity of AEs related to the SmartTwist MR Hand Drill with the SmartTip MR Drill Kit when used for intracranial access.¹

What Was the Patient Criteria?

To be eligible for the trial patients must have had lesions eligible for Laser Interstitial ThermoTherapy (LITT), been between the ages of 18 and 80, had the ability to undergo CT, PET-CT, and contrast-enhanced MRI, ECOG performance status of ≤2, supratentorial tumor localization with or without prior surgery for recurrence, life expectancy of ≥3 months, and ≥3 months since last radiotherapy of the brain.¹

Exclusion criteria included patients who have contraindications for MRI, are unfit for surgery, have a known bleeding disorder, ECOG performance status of >2, have an intratumoral cystic or hemorrhagic transformation in target tumor, and have concurrent treatment during the treatment phase with other investigational drugs or devices.¹

“For patients facing limited options and an otherwise invasive procedure, these initial results suggest meaningful potential for minimally invasive laser therapy in neuro-oncology,” said Chris Osswald, PhD, and director and global segment leader for Laser Therapy in a news release.² “We’re proud to be part of a solution that prioritizes precision, safety, accessibility, and patient outcomes. The fast, simple, and predictable workflow of ClearPoint Prism enables physicians to improve patient care today and may lay the groundwork for healthcare systems to build capacity and expertise in cell and gene therapy workflows that will transform tomorrow.”

What Is ClearPoint Prism Neuro Laser Therapy?

ClearPoint Neuro is a device, cell, and gene therapy-enabling company that offers navigation to the brain and spine. Their flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked.²

ClearPoint Prism Neuro Laser Therapy is comprised of laser applicator technology that eliminates the need for external cooling. There are various applicator sizes for different anatomical needs. The technology was evaluated in a preclinical assessment that determined that a noncooled LITT system was able to reach the target and create well-defined lesions within a margin of safety, without any AEs. It was also determined that the software was able to provide near-real-time temperature of the brain tissue.³

REFERENCES:

1. Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions. ClinicalTrials.gov. Updated January 15, 2025. Accessed October 10, 2025. https://clinicaltrials.gov/study/NCT05296122

2. ClearPoint Neuro Announces Promising Results from Brain Tumor Laser Therapy Study to be Presented at the CNS Annual Meeting in Los Angeles. News release. ClearPoint Neuro. October 7, 2025. Accessed October 10, 2025. https://tinyurl.com/39z394u8

3. Singh H, Osswald CR, Rossman A, et al. Preclinical assessment of a noncooled MR thermometry–based neurosurgical laser therapy system. J Neurosur. 2024;141(2):518-528. doi:10.3171/2023.12.JNS232154