Laser Ablation After Stereotactic Radiosurgery



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2012
End Date:August 2016

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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.


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).
We found this trial at
7
sites
Winston-Salem, North Carolina 27157
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Charlotte, North Carolina 28204
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Charlotte, NC
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Kansas City, Kansas
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Kansas City, KS
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New Haven, Connecticut 06520
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New Haven, CT
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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St. Louis, Missouri 63110
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St. Louis, MO
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