Laser Ablation After Stereotactic Radiosurgery for Patients With Metastatic Brain Tumors. (LAASR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Monteris Medical.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Monteris Medical
ClinicalTrials.gov Identifier:
NCT01651078
First received: July 24, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition
Metastatic Brain Tumors
Progression
Radiation Necrosis
Quality of Life

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Laser Ablation After Stereotactic Radiosurgery. A Post-Marketing Surveillance (Phase IV) Multicenter Observational Study.

Resource links provided by NLM:


Further study details as provided by Monteris Medical:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Pre-surgery, and up to 4 points along 6 mo follow-up ] [ Designated as safety issue: No ]
    FACT-Br Standardized Patient Reporting Instrument will be used to assess changes (relative to baseline) in Quality of Life during 6 month follow-up (post surgery)

  • Radiographic Progression [ Time Frame: 1, 2, 4, 12, 26 weeks post-surgery ] [ Designated as safety issue: Yes ]
    Standard clinical MRI scans will be assessed during the follow-up period. Assessment will be for evidence of disease progression and other indicators of treatment effect.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: throughout study (pre-op through 6 mo follow-up) ] [ Designated as safety issue: Yes ]
    CTAE 4 Adverse events will be recorded and analyzed.


Other Outcome Measures:
  • Utilization of Healthcare Resources [ Time Frame: Throughout study, collected at end of patient involvement. ] [ Designated as safety issue: No ]
    Various aspects of the clinical and non-clinical services required/utilized by the patient cohort will be collected and analyzed.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Main cohort
Patients (from normal clinical population) whom are scheduled for NeuroBlate/AutoLITT surgery to treat metastatic brain tumors previously treated with Stereotactic Radiosurgery (SRS), but have developed progression or radiation necrosis of SRS treated tumors.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will have been already, as part of normal clinical practice, schedulled for NeuroBlate/AutoLITT based neurosurgery to treat metastatic brain tumors that have previously been treated with Stereotactic Radiosurgery (SRS), but have developed either progression or radiation necrosis (as assesed by MRI) of the SRS treated tumors.

Criteria

Inclusion Criteria:

  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.

Exclusion Criteria:

  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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651078

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gene H. Barnett, MD    216.445.1379    barnetg@ccf.org   
Principal Investigator: Gene H. Barnett, MD, MBA, FACS         
Sponsors and Collaborators
Monteris Medical
Investigators
Principal Investigator: Gene H. Barnett, MD, MBA, FACS The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT01651078     History of Changes
Other Study ID Numbers: LAASR01
Study First Received: July 24, 2012
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Monteris Medical:
Metastatic Brain Tumors
Progression
Radiation Necrosis
Quality of Life

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Disease Progression
Necrosis
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 01, 2014