Clinical trial · Observational
Laser Ablation After Stereotactic Radiosurgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Brain Tumors | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Progression | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Radiation Necrosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Main cohort
- description
- 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.
Primary outcomes (1)
- measure
- Percentage of Patients With Progression-Free Survival (PFS)
- timeFrame
- Images were collected at 12 and 26 weeks post index procedure.
- description
- To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are reported.
Secondary outcomes (3)
- measure
- Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTAhluwalia M, Barnett GH, Deng D, Tatter SB, Laxton AW, Mohammadi AM, Leuthardt E, Chamoun R, Judy K, Asher A, Essig M, Dietrich J, Chiang VL. Laser ablation after stereotactic radiosurgery: a multicenter prospective study in patients with metastatic brain tumors and radiation necrosis. J Neurosurg. 2019 Mar 1;130(3):804-811. doi: 10.3171/2017.11.JNS171273. Epub 2018 May 4. PMID 29726782