ClearPoint Neuro's MR-Guided Laser Therapy Shows Promise for Brain Cancer Treatment in Phase I-II Study
核心洞察
A Phase I-II clinical study of 14 patients with glioblastoma (搜索) and grade 4 astrocytoma (搜索) demonstrated that ClearPoint Prism Neuro Laser Therapy (搜索) met safety and feasibility measures with no device-related complications reported.
The minimally invasive procedure achieved a median ablation time of just 6.5 minutes and showed improved survival compared to matched open surgery controls.
The study results suggest meaningful potential for laser thermal ablation as a treatment option for patients with limited therapeutic alternatives facing otherwise invasive brain tumor (搜索) procedures.
A Phase I-II clinical study evaluating ClearPoint Neuro (搜索)'s MR-guided laser thermal ablation system has demonstrated promising safety and efficacy results for treating patients with aggressive brain tumors, offering a potential minimally invasive alternative to traditional surgical approaches.
The single-arm study (NCT05296122), conducted at Skåne University Hospital (搜索) in Lund, Sweden, enrolled 14 patients aged 18-80 years with primary and recurrent glioblastoma (搜索) and grade 4 astrocytoma (搜索). Results showed that the ClearPoint Prism Neuro Laser Therapy (搜索) System met all safety and feasibility measures, with no device-related events or complications reported during the study period from May 12, 2022, to October 30, 2024.
Clinical Outcomes and Safety Profile
The study achieved its primary endpoint of evaluating the number and severity of adverse events related to the Tranberg Laser applicator (搜索) when used in MR-guided laser thermal ablation of brain lesions. The secondary endpoint assessed adverse events related to the SmartTwist MR Hand Drill (搜索) with the SmartTip MR Drill Kit for intracranial access.
Key findings included a median ablation time of 6.5 minutes and improved survival compared to matched open surgery controls. The procedure demonstrated a safe, feasible, and reproducible workflow for treating some of the most challenging brain tumors to manage.
Patient Selection and Study Design
Eligible patients had lesions suitable for Laser Interstitial ThermoTherapy (LITT), 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 brain radiotherapy. Patients also needed the ability to undergo CT, PET-CT, and contrast-enhanced MRI.
Exclusion criteria included MRI contraindications, surgical unfitness, known bleeding disorders, ECOG performance status >2, intratumoral cystic or hemorrhagic transformation in the target tumor, and concurrent treatment with other investigational drugs or devices during the treatment phase.
Technology and Clinical Implications
The ClearPoint Prism Neuro Laser Therapy (搜索) comprises laser applicator technology that eliminates the need for external cooling, with various applicator sizes available for different anatomical needs. Preclinical assessment determined that the noncooled LITT system could reach targets and create well-defined lesions within a safety margin, with software providing near-real-time temperature monitoring of brain tissue.
"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, Director and Global Segment Leader for Laser Therapy at ClearPoint Neuro (搜索). "We're proud to be part of a solution that prioritizes precision, safety, accessibility, and patient outcomes."
The study was led by Dr. Peter Siesjö and sponsored by CLS AB (搜索), with co-funding from ClearPoint Neuro (搜索). The ClearPoint Prism technology was displayed at the 75th Annual Congress of Neurological Surgeons in Los Angeles from October 13-15, 2025.
ClearPoint Neuro (搜索)'s flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. The company provides navigation solutions for brain and spine procedures and supports thousands of procedures worldwide through its field-based clinical specialist team.