N/A
N=18
Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
Intracranial Arteriovenous Malformations (AVM)
Bottom Line
View on ClinicalTrials.gov: NCT02576535 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms — 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fractionated stereotactic radiosurgery (Procedure); Leskell gamma unit (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms |
2 | — |
| PRIMARY Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities |
2 | — |
| PRIMARY Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM) |
4 | — |
| PRIMARY Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography |
15 | — |
| SECONDARY Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms |
3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02576535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.