N/A
N=42
Laser Ablation After Stereotactic Radiosurgery
Metastatic Brain Tumors · Progression · Radiation Necrosis · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT01651078 ↗Enrolled (actual)
42
Serious AEs
9.5%
Results posted
Aug 2019
Primary outcome: Primary: Percentage of Patients With Progression-Free Survival (PFS) — 74; 74 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Monteris Medical
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Progression-Free Survival (PFS) |
74; 74 | — |
| SECONDARY Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. |
3.8; 7.0 | — |
| SECONDARY Overall Survival |
86.5; 72.2 | — |
| SECONDARY Percentage of Patients With Laser Ablation Related Adverse Events |
0; 5; 37 | — |
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.
Eligibility Criteria
Key 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 1.5 x ULN; AST, ALT > 2.5 x ULN; alkaline phosphatase > 2.5 x ULN; serum creatinine > 1.5 x ULN).
Data sourced from ClinicalTrials.gov (NCT01651078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.