|No phase specified||Supportive care, Treatment||Active||Over 18||Pharmaceutical / Industry||LAASR01|
The need for new technologies and devices in the field of neurosurgery is well-established. In addition to the advanced engineering and medical aspects of a newly available medical device, the adoption and incorporation of such a device into healthcare organizations greatly influences it's impact on patients. As the FDA cleared NeuroBlate™ System (formerly called AutoLITT®; a minimally invasive neurosurgical device) is a new to the marketplace, there is limited experience as to how such a system is best used by healthcare organizations. This (a) post-marketing, multi-site, (b) open-label study involving (c) a single cohort of brain tumor patients that undergo routine NeuroBlate procedures is aimed at collecting, in a reasonably controlled fashion, such descriptive information, and comparing the collected information on patient Quality of Life (QoL) and healthcare utilization to published and historical information.
1. 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.
2. Target tissue/tumors treatable with one or two NeuroBlate trajectories per tumor.
3. Patient and condition amenable to NeuroBlate, but surgery is not preferred (due to lack of mass-effect, tumor located in an eloquent region, or circumstances where, in the PI-neurosurgeon's judgment, resection could result in long-lasting neurological deficits).
4. Patients with stable systemic primary malignancy.
5. KPS ≥ 70.
6. Age >18 years.
7. Tumor clearly defined on gadolinium enhanced T1 or MP-RAGE, or comparable MRI sequence with midline shift < 1 cm.
8. Minimum interval since last drug therapy:
1. 2 weeks since last non-cytotoxic therapy,
2. 3 weeks since last Avastin treatment,
3. 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy, and
4. 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.
9. Patients must be able to provide written informed consent.
1. Females who are pregnant or breast feeding.
2. Leptomeningeal metastases.
3. Uncontrolled infectious process.
4. Symptoms due to mass effect of the tumor (with steroid treatment), including marked edema, significant midline shift (e.g., > 5 mm) 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<1500/mm3), or PT and aPTT (>1.5x institutional upper limit), platelets (<100,000/mm3) or hemoglobin (<10 gm/dL), 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 the first Inclusion Criterion) involving the posterior fossa (brainstem and cerebellum) will be excluded as will patients where the anticipated treatment margin will be within 5 mm of critical intracranial structures (e.g., primary branches of cerebral vessels, dural sinuses, hypophysis or cranial nerves).
Trial Lead Organizations/Sponsors
Monteris Medical, Incorporated (US)
|Gene H. Barnett||Principal Investigator|
|Cleveland Clinic Taussig Cancer Center|
|Gene H. Barnett, MD||Ph: 216.445.1379|
|Gene H. Barnett||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01651078
ClinicalTrials.gov processed this data on October 17, 2013
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