Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
1 other identifier
interventional
18
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedResults Posted
Study results publicly available
February 18, 2016
CompletedNovember 7, 2023
November 1, 2023
11.3 years
October 12, 2015
October 19, 2015
November 2, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms
10 years
Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities
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 Outcomes (1)
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms
10 years
Study Arms (1)
Fractionated stereotactic radiosurgery
EXPERIMENTALThe 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).
Interventions
FDA approved device
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients without symptoms related to AVM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Huang
- Organization
- NYU Langone Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Huang, MD
NYU Langone Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 15, 2015
Study Start
February 1, 2000
Primary Completion
June 1, 2011
Last Updated
November 7, 2023
Results First Posted
February 18, 2016
Record last verified: 2023-11