University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
NCT Number: NCT03559556
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.
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Notify Me10 year–120 year
All sexes
Interventional
Early Phase 1
Dallas, Texas, 75390, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
6.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion criteria
CT angiography uses a CT scanner to produce detailed images of both blood vessels and tissues in various parts of the body. An iodine-rich contrast material (dye) is usually injected through a small catheter placed in a vein of the arm.
Time frame: Same day measurements
The primary endpoint of this study is to compare the volumes of targets generated from interventional cerebral arteriography (reference) to targets generated from CT angiogram and MRI alone, to assess whether noninvasive imaging approaches are noninferior to the UTSW standard
Time frame: Same day
Additional time required for CT angiogram after standard of care imaging
University of Texas Southwestern Medical Center
Other
Validation Study of Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning
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