Feasibility Study on LITT for Newly Diagnosed Glioblastoma

Study Overview
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Brief Summary
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Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).

Official Title
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Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma

Conditions
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Glioblastoma

Intervention / Treatment
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* Device: NeuroBlate System
* Drug: Radiation therapy and temozolomide


Participation Criteria
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Eligibility Criteria
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Relevant Inclusion Criteria: Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy Single enhancing lesion that is >1 cm, but < 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm) The patient must be ≥18 years of age KPS > 70 Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years. Stable cardiovascular, pulmonary health status Relevant Exclusion Criteria: Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant Uncontrolled cardiovascular conditions of hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements Pregnancy, or planning to become pregnant Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects Patients with multiple or multifocal GBM

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LITT Treatment w/radiation therapy and temozolomide<br>This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide | Device: NeuroBlate System<br>* Laser Interstitial Thermal Therapy<br>Drug: Radiation therapy and temozolomide<br>* Radiation therapy and temozolomide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing. | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival Rate | To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System | 2 Years | 
| Overall Survival | To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System | 2 Years | 
| Changes in Quality of Life | Characterize the changes in quality of life in subjects with newly diagnosed glioblastoma who are undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, NeuroBlate, LITT, Quality of Life