Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-30 @ 8:28 AM
Study NCT ID:
NCT03559556
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2018-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Validation Study of Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate whether a treatment plan based on CT angiography can accurately and precisely identify the target nidus as compared to standard cerebral arteriography fused to MRI.
Detailed Description:
Stereotactic Radiosurgery is a preferable treatment option for patients with Arteriovenous malformation (AVM) that are not surgically accessible or in patients with comorbidities that make them poor surgical candidates At University of Texas Southwestern Medical Center (UTSW), investigator routinely perform interventional cerebral arteriography on the day of the SRS procedure for improved target delineation. Even though the addition of angiography is time consuming and requires multi-modality team care, this approach has allowed UTSW to treat the smallest possible target, yet achieve excellent obliteration rates of AVM with very low toxicity from the procedure. At UTSW the investigator also use CT angiogram at the treatment team's discretion to further enhance the accurate delineation of the final treatment target volume. However, it had not been routinely done due to uncertain benefit in treatment planning and a concern for renal burden from additional intravenous (IV) contrast usage.
This prospective enrollment and conduct open-label, retrospective analysis study is to evaluate whether a target volume based on CT angiography can serve as a reliable substitute for a target based on interventional cerebral arteriography. Patients on this protocol will still get treated based on target generated by interventional cerebral arteriography but also receive CT angiography. If the target volume based on CT angiography are adequate compared to their invasive counterpart, future investigators may selectively omit performing interventional cerebral arteriography in the treatment planning for SRS of AVM. Use of CT angiography may lead to reduction in the risk from the procedure and cost, improve the efficiency of the treatment process ideally without compromising the success of the procedure, with greater patient comfort and satisfaction.
This prospective enrollment and conduct open-label, retrospective analysis study is to evaluate whether a target volume based on CT angiography can serve as a reliable substitute for a target based on interventional cerebral arteriography. Patients on this protocol will still get treated based on target generated by interventional cerebral arteriography but also receive CT angiography. If the target volume based on CT angiography are adequate compared to their invasive counterpart, future investigators may selectively omit performing interventional cerebral arteriography in the treatment planning for SRS of AVM. Use of CT angiography may lead to reduction in the risk from the procedure and cost, improve the efficiency of the treatment process ideally without compromising the success of the procedure, with greater patient comfort and satisfaction.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: