Laser Ablation After Stereotactic Radiosurgery
Basic Trial Information
|No phase specified||Supportive care, Treatment||Active||Over 18||Pharmaceutical / Industry||LAASR|
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).
Trial Contact Information
Trial Lead Organizations/Sponsors
Monteris Medical, Incorporated (US)
Yale Cancer Center
Veronica Chiang, MD
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Roukoz Chamoun, MD
Paul Camarata, MD
Michael Salacz, MD
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Eileen Jacobs, R.T.(R)(M)
Eric Leuthardt, MD
Keith Rich, MD
David Tran, MD
Clifford Robinson, MD
Wake Forest University Comprehensive Cancer Center
Wendy Jenkins, RN
Stephen Tatter, MD
Adrian Laxton, MD
Cleveland Clinic Taussig Cancer Center
Alireza Mohammadi, MD
Alizera Mohammadi, MD
Gene Barnett, MD
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01651078
ClinicalTrials.gov processed this data on April 09, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.