Laser Ablation After Stereotactic Radiosurgery (LAASR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Monteris Medical
Sponsor:
Information provided by (Responsible Party):
Monteris Medical
ClinicalTrials.gov Identifier:
NCT01651078
First received: July 24, 2012
Last updated: October 15, 2014
Last verified: July 2012
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by Monteris Medical:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline, 12 and 26 weeks post index procedure ] [ Designated as safety issue: No ]
    FACT-Br

  • Radiographic Progression [ Time Frame: 12 and 26 weeks post index procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Utilization of Healthcare Resources [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Main cohort
Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.

  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 with radiographic evidence of lesion regrowth following prior treatment with radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radionecrosis).

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).
  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, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Judith Hess    203-737-6259    Judith.Hess@yale.edu   
Principal Investigator: Veronica Chiang, MD         
United States, Missouri
Washington University in St Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Eileen Jacobs, R.T.(R)(M)    314-362-4110    Jacobse@mir.wustl.edu   
Principal Investigator: Eric Leuthardt, MD         
United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Wendy Jenkins, RN    336-716-3842    wejenkin@wakehealth.edu   
Principal Investigator: Stephen Tatter, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alireza Mohammadi, MD       MOHAMMA3@ccf.org   
Principal Investigator: Alizera Mohammadi, MD         
Sponsors and Collaborators
Monteris Medical
Investigators
Principal Investigator: Veronica Chiang, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT01651078     History of Changes
Other Study ID Numbers: LAASR
Study First Received: July 24, 2012
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 22, 2014