Metastatic Brain Tumors, Progression, Quality of Life, Radiation Necrosis
Conditions
Keywords
Metastatic Brain Tumors, Progression, Radiation Necrosis, Quality of Life
Brief 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.
Interventions
None listed
Sponsors
Monteris Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Progression-Free Survival (PFS) | Images were collected at 12 and 26 weeks post index procedure. | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. | baseline, 12 and 26 weeks post index procedure | 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. |
| Overall Survival | 12 and 26 weeks post index procedure | To describe/estimate the overall survival after the NeuroBlate Procedure. |
| Percentage of Patients With Laser Ablation Related Adverse Events | All adverse events reported through 26 weeks post index procedure | To continue to monitor factors impacting the safe and efficacious use of NeuroBlate |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Main Cohort |
|---|---|
| Age, Continuous | 60 years |
| Biopsy-confirmed radiation necrosis or metastatic brain tumor | 39 patients |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 4 / 42 |
Outcome results
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.
Time frame: Images were collected at 12 and 26 weeks post index procedure.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeuroBlate Procedure | Percentage of Patients With Progression-Free Survival (PFS) | 12-weeks | 74 percentage of patients |
| NeuroBlate Procedure | Percentage of Patients With Progression-Free Survival (PFS) | Last Follow-up | 74 percentage of patients |
Secondary
Overall Survival
To describe/estimate the overall survival after the NeuroBlate Procedure.
Time frame: 12 and 26 weeks post index procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NeuroBlate Procedure | Overall Survival | 12-week Kaplan-Meier survival | 86.5 percentage of patients |
| NeuroBlate Procedure | Overall Survival | 26-week Kaplan-Meier survival | 72.2 percentage of patients |
Secondary
Percentage of Patients With Laser Ablation Related Adverse Events
To continue to monitor factors impacting the safe and efficacious use of NeuroBlate
Time frame: All adverse events reported through 26 weeks post index procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NeuroBlate Procedure | Percentage of Patients With Laser Ablation Related Adverse Events | Serious events associated with NeuroBlate | 0 Participants |
| NeuroBlate Procedure | Percentage of Patients With Laser Ablation Related Adverse Events | Non-serious events associated with NeuroBlate | 5 Participants |
| NeuroBlate Procedure | Percentage of Patients With Laser Ablation Related Adverse Events | No NeuroBlate-related adverse event | 37 Participants |
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.
Time frame: baseline, 12 and 26 weeks post index procedure
Population: Due to study attrition, the full cohort was unavailable for analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| NeuroBlate Procedure | Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. | Change in 12-week FACT-Br from Baseline | 3.8 change in FACT-Br score |
| NeuroBlate Procedure | Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. | Change in 26-week FACT-Br from Baseline | 7.0 change in FACT-Br score |