Early Phase 1
N=14
Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning
Arteriovenous Malformations
Bottom Line
View on ClinicalTrials.gov: NCT03559556 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Target Volume Difference Between Standard of Care vs. CT Angiogram and MRI Alone — 1.1; 1.3 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- CT angiography (Other)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Volume Difference Between Standard of Care vs. CT Angiogram and MRI Alone |
1.1; 1.3 | — |
| SECONDARY CT Angiogram Additional Time |
8 | — |
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.
Eligibility Criteria
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:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- Patients without a documented AVM.
- Patients with a contraindication to CT or MRI such as contrast allergy, kidney failure or implanted metal devices or foreign bodies or severe claustrophobia.
- Use of Nephrotoxic drugs, such as gentamycin, high-dose nonsteroidal anti-inflammatory drugs, or certain chemotherapeutic drugs within 10 days of the procedure.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Patients must not be pregnant at the time of SRS treatment.
Data sourced from ClinicalTrials.gov (NCT03559556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.