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Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576535
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intracranial Arteriovenous Malformations (AVM) Procedure: Fractionated stereotactic radiosurgery Device: Leskell gamma unit Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations
Study Start Date : February 2000
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms [ Time Frame: 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Paul Huang, MD NYU Langone Medical Center
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02576535    
Other Study ID Numbers: 8844
First Posted: October 15, 2015    Key Record Dates
Results First Posted: February 18, 2016
Last Update Posted: February 18, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
 Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases