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Laser Ablation After Stereotactic Radiosurgery (LAASR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01651078
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : August 9, 2019
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Monteris Medical

Study Description
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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.

Condition or disease
Metastatic Brain Tumors Progression Radiation Necrosis Quality of Life

Study Design
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Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Ablation After Stereotactic Radiosurgery
Study Start Date : July 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Patients With Progression-Free Survival (PFS) [ Time Frame: 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 Outcome Measures :
  1. Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. [ Time Frame: 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.

  2. Overall Survival [ Time Frame: 12 and 26 weeks post index procedure ]
    To describe/estimate the overall survival after the NeuroBlate Procedure.

  3. Percentage of Patients With Laser Ablation Related Adverse Events [ Time Frame: All adverse events reported through 26 weeks post index procedure ]
    To continue to monitor factors impacting the safe and efficacious use of NeuroBlate


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651078


Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University in St Louis
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, United States, 28204
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Monteris Medical
Investigators
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Principal Investigator: Veronica Chiang, MD Yale School of Medicine
More Information
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Publications of Results:

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Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT01651078    
Other Study ID Numbers: LAASR
First Posted: July 26, 2012    Key Record Dates
Results First Posted: August 9, 2019
Last Update Posted: August 24, 2021
Last Verified: August 2021
Keywords provided by Monteris Medical:
Metastatic Brain Tumors
Progression
Radiation Necrosis
Quality of Life
Additional relevant MeSH terms:
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Brain Neoplasms
Disease Progression
Necrosis
Disease Attributes
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases