Laser Ablation After Stereotactic Radiosurgery

Completed

Conditions: Metastatic Brain Tumors
Quality of Life
Progression
Radiation Necrosis

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient has signed and received a copy of the Informed Consent Form
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.
Karnofsky Performance Status (KPS) ≥ 60.

Key

Exclusion Criteria

Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following index procedure.
Leptomeningeal metastases.
Uncontrolled infectious process.
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<1000/mm), platelets (<100,000/mm) or the administration of antiplatelet agents (aspirin, plavix etc) or anticoagulation 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).

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Progression-Free Survival (PFS)	Images were collected at 12 and 26 weeks post index procedure.	To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are reported.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.	baseline, 12 and 26 weeks post index procedure	FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used.
Percentage of Patients With Laser Ablation Related Adverse Events	All adverse events reported through 26 weeks post index procedure	To continue to monitor factors impacting the safe and efficacious use of NeuroBlate
Overall Survival	12 and 26 weeks post index procedure	To describe/estimate the overall survival after the NeuroBlate Procedure.

Locations (7): Wake Forest School of Medicine
🇺🇸
Winston-Salem, North Carolina, United States
Washington University in St Louis
🇺🇸
Saint Louis, Missouri, United States
Yale School of Medicine
🇺🇸
New Haven, Connecticut, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Kansas University Medical Center
🇺🇸
Kansas City, Kansas, United States
Carolina Neurosurgery & Spine Associates
🇺🇸
Charlotte, North Carolina, United States
Thomas Jefferson University
🇺🇸
Philadelphia, Pennsylvania, United States