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Early Phase 1 N=14 Other

Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning

Arteriovenous Malformations

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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