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Completed

NCT Number: NCT01651078

Laser Ablation After Stereotactic Radiosurgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale School of Medicine, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Patient has signed and received a copy of the Informed Consent Form
  • 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.
  • Karnofsky Performance Status (KPS) ≥ 60.

Key Exclusion Criteria:

  • Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following index procedure.
  • Leptomeningeal metastases.
  • Uncontrolled infectious process.
  • Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.
  • Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.
  • 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.
  • 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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Monteris Medical

Industry

Registry information

Acronym: LAASR

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 26, 2012
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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