Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Intracranial Arteriovenous Malformations (AVM) Clinical Trial

Official title:

Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576535
• Other study ID #: 8844
• Status: Completed
• Phase: N/A
• Start date: February 2000

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations
• Intracranial Arteriovenous Malformations (AVM)

Intervention

Procedure:
• Fractionated stereotactic radiosurgery

Device:
• Leskell gamma unit
FDA approved device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms		10 years
Primary	Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities		10 years
Primary	Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)		10 years
Primary	Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography		10 years
Secondary	Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms		10 years