Trial Outcomes & Findings for Laser Ablation After Stereotactic Radiosurgery (NCT NCT01651078)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

44 participants

Primary outcome timeframe

Images were collected at 12 and 26 weeks post index procedure.

Results posted on

2024-04-15

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	42
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laser Ablation After Stereotactic Radiosurgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Main Cohort n=42 Participants 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.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Biopsy-confirmed radiation necrosis or metastatic brain tumor	39 patients n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NeuroBlate Procedure n=27 Participants 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.
Percentage of Patients With Progression-Free Survival (PFS) 12-weeks	74 percentage of patients
Percentage of Patients With Progression-Free Survival (PFS) Last Follow-up	74 percentage of patients

SECONDARY outcome

Timeframe: baseline, 12 and 26 weeks post index procedure

Population: Due to study attrition, the full cohort was unavailable for analysis.

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.

Outcome measures

Outcome measures
Measure	NeuroBlate Procedure n=42 Participants 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.
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 Interval -71.8 to 40.0
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 Interval -34.7 to 34.3

SECONDARY outcome

Timeframe: 12 and 26 weeks post index procedure

To describe/estimate the overall survival after the NeuroBlate Procedure.

Outcome measures

Outcome measures
Measure	NeuroBlate Procedure n=42 Participants 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.
Overall Survival 12-week Kaplan-Meier survival	86.5 percentage of patients
Overall Survival 26-week Kaplan-Meier survival	72.2 percentage of patients

SECONDARY outcome

Timeframe: All adverse events reported through 26 weeks post index procedure

To continue to monitor factors impacting the safe and efficacious use of NeuroBlate

Outcome measures

Outcome measures
Measure	NeuroBlate Procedure n=42 Participants 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.
Percentage of Patients With Laser Ablation Related Adverse Events Serious events associated with NeuroBlate	0 Participants
Percentage of Patients With Laser Ablation Related Adverse Events Non-serious events associated with NeuroBlate	5 Participants
Percentage of Patients With Laser Ablation Related Adverse Events No NeuroBlate-related adverse event	37 Participants

Adverse Events

Main Cohort

Serious events: 4 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Main Cohort n=42 participants at risk 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.
Surgical and medical procedures Pulmonary or other air embolism	4.8% 2/42 • Number of events 2 • 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.
Nervous system disorders Seizures	4.8% 2/42 • Number of events 2 • 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.
Surgical and medical procedures Hypotension	2.4% 1/42 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Nissa Mollema (Clinical Operations Manager)

Monteris Medical

Phone: 763-253-4710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place