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The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlateâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main cohort | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Progression-Free Survival (PFS) | 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. | Images were collected at 12 and 26 weeks post index procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. | FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients with radiographic evidence of lesion regrowth following prior treatment with radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radionecrosis).
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Chiang, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States | ||
| Kansas University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29726782 | Result | Ahluwalia 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. |
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Forty-four (44) patients were enrolled between October 2012 and December 2015 across six centers in the United States (per the protocol, LAASR enrolled all patients who were scheduled to undergo a NeuroBlate procedure). Forty-two (42) patients underwent the procedure and were followed under the protocol as the "NeuroBlate Procedure" treatment arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | NeuroBlate Procedure | 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 underwent the NeuroBlate procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Cohort | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients With Progression-Free Survival (PFS) | 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. | 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. | Posted | Number | percentage of patients | Images were collected at 12 and 26 weeks post index procedure. |
|
Adverse events were collected from the time of patient consent (prior to the surgical procedure) to study withdraw/completion, up to 26 weeks.
Events adjudicated as surgery- or LITT- associated are described in the adverse events section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Main Cohort | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary or other air embolism | Surgical and medical procedures |
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Limitations are discussed by the physicians in the full publication of the LAASR study data (open access): http://thejns.org/doi/pdf/10.3171/2017.11.JNS171273
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nissa Mollema (Clinical Operations Manager) | Monteris Medical | 763-253-4710 | nmollema@monteris.com |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| baseline, 12 and 26 weeks post index procedure |
| Overall Survival | To describe/estimate the overall survival after the NeuroBlate Procedure. | 12 and 26 weeks post index procedure |
| Percentage of Patients With Laser Ablation Related Adverse Events | To continue to monitor factors impacting the safe and efficacious use of NeuroBlate | All adverse events reported through 26 weeks post index procedure |
| Kansas City |
| Kansas |
| 66160 |
| United States |
| Washington University in St Louis | St Louis | Missouri | 63110 | United States |
| Carolina Neurosurgery & Spine Associates | Charlotte | North Carolina | 28204 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Biopsy-confirmed radiation necrosis or metastatic brain tumor | Number | patients |
|
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. |
|
|
| Secondary | Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. | FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used. | Due to study attrition, the full cohort was unavailable for analysis. | Posted | Median | Full Range | change in FACT-Br score | baseline, 12 and 26 weeks post index procedure |
|
|
|
| Secondary | Overall Survival | To describe/estimate the overall survival after the NeuroBlate Procedure. | Posted | Number | percentage of patients | 12 and 26 weeks post index procedure |
|
|
|
| Secondary | Percentage of Patients With Laser Ablation Related Adverse Events | To continue to monitor factors impacting the safe and efficacious use of NeuroBlate | Posted | Count of Participants | Participants | All adverse events reported through 26 weeks post index procedure |
|
|
|
| 8 |
| 42 |
| 4 |
| 42 |
| 0 |
| 42 |
| Seizures | Nervous system disorders |
|
| Hypotension | Surgical and medical procedures |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|