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LAASR: Laser Ablation After Stereotactic Radiosurgery
- Primary Objectives
- To describe the impact on QoL and local (CNS) progression-free survival rate in patients with failed radiosurgery for metastatic brain tumors treated with NeuroBlate.
- Secondary Objectives
- To estimate the rate of local (site of NeuroBlate) failure at 3 months
- To assess healthcare utilization in this cohort
- To describe/estimate the overall survival
- To assess the neurocognitive effects of NeuroBlate (which could confound primary QoL objectives)
- To continue to monitor factors impacting the safe and efficacious use of NeuroBlate
- Up to 3 target supratentorial metastatic lesions (up to 5 cm in maximum dimension perpendicular to planned primary trajectory axis) previously treated with SRS, with radiological evidence of progression, pseudoprogression or radionecrosis. Subject may have up to 5 non target lesions present. Non target lesions must be small (less than 3 mm) or not expected (in Investigator's judgment) to contribute to symptomology during the course of the study or confound interpretation of radiological and clinical measures.
- Target tissue/tumors treatable with one or two NeuroBlate trajectories per tumor.
- Patient and condition amenable to NeuroBlate, but surgery is not preferred (due to lack of mass-effect, tumor located in an eloquent region, or circumstances where, in the PI-neurosurgeon's judgment, resection could result in long-lasting neurological deficits).
- Patients continuing to undergo aggressive treatment for primary malignancy and deemed reasonable surgical candidates by their medical oncologists.
- KPS ≥ 70
- Age ≥18 years
- Tumor clearly defined on gadolinium enhanced T1 or MP-RAGE, or comparable MRI sequence with midline shift < 1 cm. LITT can be performed shortly after administration of chemotherapy as long as bone marrow suppression causing neutropenia, thrombocytopenia or anemia is not expected concurrent with the procedure. LITT can also be performed in conjunction with systemic immunotherapies or clinical trial agents as long as it is accepted as standard for any neurosurgical procedure within each individual institution There however needs to be at least 3 weeks between last administration of Avastin and the LITT procedure. For patients on anti-tumor agents, sufficient time must have passed to ensure adequate bone marrow
- Patients must be able to provide written informed consent
- Females who are pregnant or breast feeding.
- Leptomeningeal metastases.
- Uncontrolled infectious process.
- Symptoms due to mass effect of the tumor (with steroid treatment), including marked edema, significant midline shift (e.g., > 5 mm) or high intracranial pressure, where surgical debulking in the first 30 days post NeuroBlate treatment would be required for therapy.
- Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) 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.
- Abnormal absolute neutrophil count (ANC<1500/mm3), or PT and aPTT (>1.5x institutional upper limit), platelets (<100,000/mm3) or hemoglobin (<10 gm/dL), or the administration of antiplatelet agents within 7 days prior to treatment.
- Inadequate bone marrow, liver and renal function (e.g., total bilirubin > 1.5 x ULN; AST, ALT > 2.5 x ULN; alkaline phosphatase > 2.5 x ULN; serum creatinine > 1.5 x ULN).
- 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.
- Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent safe participation or otherwise render this patient ineligible for the study.
- Patients with treatable tumors (those of the size described in Inclusion Criterion # 1) involving the posterior fossa (brainstem and cerebellum) will be excluded as will patients where the anticipated treatment margin will be within 5 mm of critical intracranial structures (e.g., primary branches of cerebral vessels, dural sinuses, hypophysis or cranial nerves).
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