Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Not Applicable

Completed

• Conditions: Intracranial Arteriovenous Malformations (AVM)
• Interventions: Procedure: Fractionated stereotactic radiosurgery; Device: Leskell gamma unit

• Registration Number: NCT02576535
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2000-02
• Primary Completion: 2011-06
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-14
• Study First Posted: 2015-10-15
• Results First Submitted: 2015-10-19
• Results First Submitted QC: 2016-01-21
• Results First Posted: 2016-02-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

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Exclusion Criteria

• Patients without symptoms related to AVM

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fractionated stereotactic radiosurgery	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).
Fractionated stereotactic radiosurgery	Leskell gamma unit	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms	10 years