Feasibility Study on LITT for Newly Diagnosed Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Device: NeuroBlate SystemDrug: Radiation therapy and temozolomide
- Registration Number
- NCT02880410
- Lead Sponsor
- Monteris Medical
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LITT Treatment w/radiation therapy and temozolomide Radiation therapy and temozolomide This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide LITT Treatment w/radiation therapy and temozolomide NeuroBlate System This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
- Primary Outcome Measures
Name Time Method Adverse Events 2 Years 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.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival Rate 2 Years To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System
Overall Survival 2 Years To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System
Changes in Quality of Life 2 Years 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
Trial Locations
- Locations (4)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States