Glioblastoma
Conditions
Keywords
Glioblastoma, NeuroBlate, LITT, Quality of Life
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).
Interventions
DRUGRadiation therapy and temozolomide
Radiation therapy and temozolomide
DEVICENeuroBlate System
Laser Interstitial Thermal Therapy
Sponsors
Monteris Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Relevant Inclusion Criteria: 1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy 2. Single enhancing lesion that is \>1 cm, but \< 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm) 3. The patient must be ≥18 years of age 4. KPS \> 70 5. 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. 6. Stable cardiovascular, pulmonary health status Relevant
Exclusion criteria
1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs 2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant 3. Uncontrolled cardiovascular conditions of hypertension (systolic \>180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage 4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements 5. Pregnancy, or planning to become pregnant 6. 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 7. Patients with multiple or multifocal GBM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed