Laser Ablation After Stereotactic Radiosurgery (LAASR)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Progression; Radiation Necrosis; Metastatic Brain Tumors

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina Neurosurgery & Spine Associates
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Monteris Medical
• Investigators: Principal Investigator: Veronica Chiang, MD, Yale School of Medicine

Publications and helpful links

General Publications

• 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. 2018 May 4;130(3):804-811. doi: 10.3171/2017.11.JNS171273.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimated): July 26, 2012

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Progression; Quality of Life; Metastatic Brain Tumors; Radiation Necrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Central Nervous System Neoplasms; Nervous System Neoplasms; Disease Progression; Brain Neoplasms; Necrosis
• Other Study ID Numbers: LAASR