Laser Ablation After Stereotactic Radiosurgery

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Basic Trial Information

PhaseTypeAgeTrial IDs
No phase specifiedSupportive care, TreatmentOver 18LAASR
NCI-2014-00683, LAASR01, NCT01651078

Trial Description

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.

Eligibility Criteria

Inclusion 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).

Exclusion 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).

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Monteris Medical

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01651078

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.