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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated stereotactic radiosurgery | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated stereotactic radiosurgery | Procedure |
| ||
| Leskell gamma unit |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Huang, MD | NYU Langone Medical Center | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms | Posted | Number | participants | 10 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Huang | NYU Langone Medical Center | 212-263-6414 | Paul.Huang@nyumc.org |
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| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Device |
FDA approved device |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms | Posted | Number | participants | 10 years |
|
|
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| Primary | Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities | Posted | Number | participants | 10 years |
|
|
|
| Primary | Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM) | Posted | Number | participants | 10 years |
|
|
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| Primary | Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography | Posted | Number | participants | 10 years |
|
|
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| Post-Hoc | Number of Participants Experiencing Seizures | Posted | Number | participants | 10 years |
|
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| 0 |
| 18 |
| 0 |
| 18 |
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| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |