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MONT 1311   |   12-007
LAASR: Laser Ablation After Stereotactic Radiosurgery

Main Campus

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  1. Primary Objectives
    • to describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System.
  2. Secondary Objectives
    • To assess the neurocognitive effects of NeuroBlate via Qol and neurocognitive assessment tools
    • To describe/estimate the overall survival and
    • To continue to monitor factors impacting the safe and efficacious use of NeuroBlate

Inclusion Criteria
  1. Patient has signed and received a copy of the Informed Consent Form (see Appendix A)
  2. Patient may have up to 3 target supratentorial metastatic lesions (up to 5 cm in maximum dimension perpendicular to planned primary trajectory axis) previously treated with SRS, with radiological evidence of progression, pseudoprogression or radionecrosis. Subject may have up to 5 non target lesions present. Non target lesions must be small (less than 3 mm) or not expected (in Investigator's judgment) to contribute to symptomology during the course of the study or confound interpretation of radiological and clinical measures.
  3. Preferred management for the tissue/tumors is stereotactic biopsy (to characterize tissue) followed by NeuroBlate in the opinion of the surgeon.
  4. Patients continuing to undergo aggressive treatment for primary malignancy and deemed reasonable surgical candidates by their medical oncologists.
  5. KPS ≥ 60
  6. Age ≥18 years
  7. Tumor clearly defined on gadolinium enhanced T1, MP-RAGE, or comparable MRI sequence

Exclusion Criteria
  1. Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following LITT.
  2. Leptomeningeal metastases.
  3. Uncontrolled infectious process.
  4. Progressive symptoms due to mass effect of the tumor (with steroid treatment), including marked edema, significant midline shift (e.g., > 1 cm) or high intracranial pressure, where surgical debulking in the first 30 days post NeuroBlate treatment would be required for therapy.
  5. Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.
  6. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.
  7. Abnormal absolute neutrophil count (ANC<1000/mm), platelets (<100,000/mm), or the administration of antiplatelet agents within 7 days prior to treatment.
  8. 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).
  9. Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects.
  10. Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent safe participation or otherwise render this patient ineligible for the study.
  11. Patients with treatable tumors (those of the size described in Inclusion Criterion # 1) involving the posterior fossa (brainstem and cerebellum) will be excluded. Further delineation of these patients will be based on the presence/absence of radionecrosis (via biopsy) and the site of primary malignancy and will be documented in the appropriate case report form (see Appendix C, CRF schedule).

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