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OpenTrials
Completed

NCT Number: NCT02576535

Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

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.

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Key information

Conditions

Intracranial Arteriovenous Malformations (AVM) Arteriovenous Malformations Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Nervous System Diseases Nervous System Malformations Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractionated stereotactic radiosurgery

Procedure

Leskell gamma unit

Device

FDA approved device

Other names: Gamma Knife

Primary outcomes

  1. Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms

    Time frame: 10 years

  2. Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities

    Time frame: 10 years

  3. Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)

    Time frame: 10 years

  4. Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography

    Time frame: 10 years

Secondary outcomes

  1. Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2000
Primary completion
2011
First posted
Oct 15, 2015
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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