search
Back to results

Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Primary Purpose

Intracranial Arteriovenous Malformations (AVM)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractionated stereotactic radiosurgery
Leskell gamma unit
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Arteriovenous Malformations (AVM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients age 18 or older
  • Inpatients and outpatients, referred for radiosurgical treatment of an arteriovenous malformation
  • Patients with lesions greater than 10 cc, who are currently symptomatic from the AVM (hemorrhage, seizure, or ischemia from steal phenomenon)

Exclusion Criteria:

  • Patients without symptoms related to AVM

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Fractionated stereotactic radiosurgery

    Arm Description

    The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).

    Outcomes

    Primary Outcome Measures

    Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms
    Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities
    Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)
    Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography

    Secondary Outcome Measures

    Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms

    Full Information

    First Posted
    October 12, 2015
    Last Updated
    January 21, 2016
    Sponsor
    NYU Langone Health
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02576535
    Brief Title
    Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
    Official Title
    Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2000 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Stereotactic radiosurgery is a well established treatment option for arteriovenous malformations (AVMs). The potential complications related to radiosurgery are well documented and are predominately related to radiation effects to the surrounding brain parenchyma. These risks increase with larger lesions, requiring a concommitant reduction in the amount of radiation that can be delivered. This reduction in radiation dose decreases the efficacy of treatment. The broad, long-term objectives of this proposal are 1) to determine the role of fractionated stereotactic radiosurgery in the treatment of large (>10cc) AVMs; 2) to evaluate the complication rates related to fractionating these doses compared to conventional stereotactic treatment 3) to evaluate the success rate of treating large AVMs with this protocol.
    Detailed Description
    This research project will involve performing a preoperative MRI and angiogram on patients harboring an AVM to determine the feasibility of treating the lesion with gamma knife radiosurgery. Patient with lesions greater than 10 cc will be studied. Each patient will have a Magnetic resonance angiography (MRA) with gadolinium and an angiogram immediately before each radiation treatment. If there is a contraindication for MRI examination (pacemaker or any other implanted ferromagnetic material), a CT angiogram will be obtained instead. Each treatment will be spaced at least 3 months apart. Follow-up MRIs or CT scans will be obtained at 6 month intervals. A follow-up angiogram will be obtained when there is radiographic evidence of complete occlusion based on the MRI images, or at 3 years after the procedure, whichever occurs first.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Arteriovenous Malformations (AVM)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fractionated stereotactic radiosurgery
    Arm Type
    Experimental
    Arm Description
    The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).
    Intervention Type
    Procedure
    Intervention Name(s)
    Fractionated stereotactic radiosurgery
    Intervention Type
    Device
    Intervention Name(s)
    Leskell gamma unit
    Other Intervention Name(s)
    Gamma Knife
    Intervention Description
    FDA approved device
    Primary Outcome Measure Information:
    Title
    Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms
    Time Frame
    10 years
    Title
    Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities
    Time Frame
    10 years
    Title
    Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)
    Time Frame
    10 years
    Title
    Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography
    Time Frame
    10 years
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients age 18 or older Inpatients and outpatients, referred for radiosurgical treatment of an arteriovenous malformation Patients with lesions greater than 10 cc, who are currently symptomatic from the AVM (hemorrhage, seizure, or ischemia from steal phenomenon) Exclusion Criteria: Patients without symptoms related to AVM
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Huang, MD
    Organizational Affiliation
    NYU Langone Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

    We'll reach out to this number within 24 hrs