Clinical Trial: Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

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 Summary:

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.


Sponsor: New York University School of Medicine

Current Primary Outcome:

  • Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms [ Time Frame: 10 years ]
  • Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities [ Time Frame: 10 years ]
  • Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM) [ Time Frame: 10 years ]
  • Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography [ Time Frame: 10 years ]


Original Primary Outcome:

  • Number of participants with presence of T2 weighted changes on serial MRI exam not associated with neurological symptoms [ Time Frame: 3 years ]
  • Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms [ Time Frame: 3 years ]
  • Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities [ Time Frame: 3 years ]
  • Number of participants experiencing hemorrhage from the AVM [ Time Frame: 3 years ]
  • Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography [ Time Frame: 3 years ]


Current Secondary Outcome: Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms [ Time Frame: 10 years ]

Original Secondary Outcome:

Information By: New York University School of Medicine

Dates:
Date Received: October 12, 2015
Date Started: February 2000
Date Completion:
Last Updated: January 21, 2016
Last Verified: January 2016