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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with AVM requiring radiotherapy | Experimental | Patients on this protocol will still get treated based on target generated by interventional cerebral arteriography but also receive CT angiography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT angiography | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Volume Difference Between Standard of Care vs. CT Angiogram and MRI Alone | 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 | Same day measurements |
| Measure | Description | Time Frame |
|---|---|---|
| CT Angiogram Additional Time | Additional time required for CT angiogram after standard of care imaging | Same day |
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Inclusion Criteria:
Documented AVM with draining vein(s).
Adequate renal function (serum Creatinine < 1.5 mg/dl within 30 days of SRS) to undergo contrast CT and interventional cerebral arteriography on the same day, as determined by treating physicians.
AVM must be physically separated from the optic pathway, brainstem or spinal cord.
The maximum diameter of AVM nidus must be less than 3.5 cm and/or less than 12 cc.
Age ≥ 10 years.
All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
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:
Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Timmerman, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient With AVM Requiring Radiotherapy | Patients who received planning CT angiogram in addition to standard of care CT angiography: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients enrolled to study
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient With AVM Requiring Radiotherapy | Patients who received planning CT angiogram in addition to standard of care CT angiography: 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. |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Target Volume Difference Between Standard of Care vs. CT Angiogram and MRI Alone | 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 | Median volume between standard of care target volumes (mL) vs. CT Angiogram in addition to standard of care. Standard of care is considered reference volume | Posted | Median | Standard Deviation | mL | Same day measurements |
|
1 month
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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 | Patient With AVM Requiring Radiotherapy | Patients who received planning CT angiogram in addition to standard of care CT angiography: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urine discoloration | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Timmerman | University of Texas Southwestern Medical Center | 214-645-7637 | robert.timmerman@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2021 | May 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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The study proposes 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.
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Neurosurgeon who contoured AVM nidus using interventional cerebral arteriography.
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard of Care MRI and IR angiogram |
|
|
| Secondary | CT Angiogram Additional Time | Additional time required for CT angiogram after standard of care imaging | Time required for CT angiogram | Posted | Mean | Standard Deviation | Minutes | Same day |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 4 |
| 13 |
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Edema limbs | General disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| blurred vision | Eye disorders | Systematic Assessment |
|
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |