Intracranial Arteriovenous Malformations (AVM)
Conditions
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.
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.
Interventions
DEVICELeskell gamma unit
FDA approved device
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms | 10 years |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Fractionated stereotactic radiosurgery
Leskell gamma unit: FDA approved device | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Fractionated Stereotactic Radiosurgery |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 3 participants |
| Race/Ethnicity, Customized Black, not of Hispanic-American Origin | 4 participants |
| Race/Ethnicity, Customized Hispanic-American | 4 participants |
| Race/Ethnicity, Customized White, not of Hispanic-American Origin | 7 participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)
Time frame: 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM) | 4 participants |
Primary
Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography
Time frame: 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography | 15 participants |
Primary
Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities
Time frame: 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities | 2 participants |
Primary
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms
Time frame: 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms | 2 participants |
Secondary
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms
Time frame: 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms | 3 participants |
Post Hoc
Number of Participants Experiencing Seizures
Time frame: 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fractionated Stereotactic Radiosurgery | Number of Participants Experiencing Seizures | 3 participants |