Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
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|ClinicalTrials.gov Identifier: NCT02576535|
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Arteriovenous Malformations (AVM)||Procedure: Fractionated stereotactic radiosurgery Device: Leskell gamma unit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations|
|Study Start Date :||February 2000|
|Actual Primary Completion Date :||June 2011|
Experimental: Fractionated stereotactic radiosurgery
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).
Procedure: Fractionated stereotactic radiosurgery
Device: Leskell gamma unit
FDA approved device
Other Name: Gamma Knife
- 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 ]
- Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576535
|Principal Investigator:||Paul Huang, MD||NYU Langone Medical Center|