Laser Ablation After Stereotactic Radiosurgery
Laser Ablation After Stereotactic Radiosurgery
The need for new technologies and devices in the field of neurosurgery is well established.
 In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy
 tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue
 caused by tumors and lesions. This post-marketing, multi-center study will include patients
 with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for
 NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and,
 where feasible, healthcare utilization data for publication.
Key Inclusion Criteria:

 1. Patient has signed and received a copy of the Informed Consent Form

 2. Patient may have up to 3 target supratentorial metastatic lesions previously treated
 with stereotactic radiosurgery, with radiological evidence of progression,
 pseudoprogression or radionecrosis. Subject may have additional non target lesions
 present as long as they are not expected (in Investigator's judgment) to contribute to
 symptomatology during the course of the study or confound interpretation of
 radiological and clinical measures.

 3. Karnofsky Performance Status (KPS) ≥ 60.

 Key Exclusion Criteria:

 1. Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months
 following index procedure.

 2. Leptomeningeal metastases.

 3. Uncontrolled infectious process.

 4. Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac
 dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.

 5. Serious infection, immunosuppression or concurrent medical condition (chronic or acute
 in nature) that may prevent safe participation or ability to meet follow-up
 requirements.

 6. Abnormal absolute neutrophil count (ANC<1000/mm), platelets (<100,000/mm) or the
 administration of antiplatelet agents (aspirin, plavix etc) or anticoagulation within
 7 days prior to treatment.

 7. 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).