Laser Ablation After Stereotactic Radiosurgery

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedSupportive care, TreatmentActiveOver 18Pharmaceutical / IndustryLAASR
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

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

Monteris Medical, Incorporated (US)

    Veronica Chiang, MD, Principal Investigator

    Trial Sites

    U.S.A.

    Connecticut
    New Haven

    Yale Cancer Center

    Judith Hess
    Ph: 203-737-6259
    Email: Judith.Hess@yale.edu

    Veronica Chiang, MD
    Principal Investigator

    Kansas
    Kansas City

    Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Jason Gorup
    Ph: 913-951-1111
    Email: jgorup@kumc.edu

    Roukoz Chamoun, MD
    Principal Investigator

    Paul Camarata, MD
    Sub-Investigator

    Michael Salacz, MD
    Sub-Investigator

    Missouri
    St. Louis

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Eileen Jacobs, R.T.(R)(M)
    Ph: 314-362-4110
    Email: Jacobse@mir.wustl.edu

    Eric Leuthardt, MD
    Principal Investigator

    Keith Rich, MD
    Sub-Investigator

    David Tran, MD
    Sub-Investigator

    Clifford Robinson, MD
    Sub-Investigator

    North Carolina
    Winston-Salem

    Wake Forest University Comprehensive Cancer Center

    Wendy Jenkins, RN
    Ph: 336-716-3842
    Email: wejenkin@wakehealth.edu

    Stephen Tatter, MD
    Principal Investigator

    Adrian Laxton, MD
    Sub-Investigator

    Ohio
    Cleveland

    Cleveland Clinic Taussig Cancer Center

    Alireza Mohammadi, MD
    Email: MOHAMMA3@ccf.org

    Alizera Mohammadi, MD
    Principal Investigator

    Gene Barnett, MD
    Sub-Investigator

    Pennsylvania
    Philadelphia

    Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Kara Pigott
    Ph: 215-503-9110
    Email: Kara.Pigott@jefferson.edu

    Kevin Judy
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01651078
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.