Laser Ablation After Stereotactic Radiosurgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Brain Tumors Progression Radiation Necrosis Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main cohort

Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.

No interventions assigned to this group

Eligibility Criteria

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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.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No