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