Laser Ablation After Stereotactic Radiosurgery
Conditions
Metastatic Brain Tumors - Progression - Radiation Necrosis - Quality of Life
Conditions: official terms
Brain Neoplasms - Disease Progression - Necrosis
Conditions: Keywords
Metastatic Brain Tumors, Progression, Radiation Necrosis, Quality of Life
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: 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).
Locations
Yale School of Medicine
New Haven, Connecticut, United States
Status: Recruiting
Contact: Judith Hess - 203-737-6259 - Judith.Hess@yale.edu
Kansas University Medical Center
Kansas City, Kansas, United States
Status: Recruiting
Contact: Jason Gorup - 913-951-1111 - jgorup@kumc.edu
Washington University in St Louis
St. Louis, Missouri, United States
Status: Recruiting
Contact: Eileen Jacobs, R.T.(R)(M) - 314-362-4110 - Jacobse@mir.wustl.edu
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States
Status: Recruiting
Contact: Peggy Boltes - 704-376-1605 - peggy.boltes@cnsa.com
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States
Status: Recruiting
Contact: Wendy Jenkins, RN - 336-716-3842 - wejenkin@wakehealth.edu
Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Contact: Cathy Brewer - 216-444-7937 - brewerc1@ccf.org
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Kara Pigott - 215-503-9110 - Kara.Pigott@jefferson.edu
Start Date
July 2012
Completion Date
December 2015
Sponsors
Monteris Medical
Source
Monteris Medical
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page