NCT03559556

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

Completed EARLY_PHASE1 Results posted Last updated 15 October 2024

What this trial tests

EARLY_PHASE1 trial testing CT angiography in Arteriovenous Malformations in 14 participants. Completed in 24 June 2024.

Timeline

25 July 2019

Primary endpoint
10 September 2021

24 June 2024

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	14
Start date	25 July 2019
Primary completion	10 September 2021
Estimated completion	24 June 2024
Sites	1 location across United States

Drugs / interventions tested

• CT angiography

Conditions studied

• Arteriovenous Malformations — all drugs for Arteriovenous Malformations →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 10 to 120, any sex, with Arteriovenous Malformations. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Target Volume Difference Between Standard of Care vs. CT Angiogram and MRI Alone Primary · 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

Group	Value	95% CI
CT Angiogram in Addition to Standard of Care	1.1	± 2.5
Standard of Care	1.3	± 2.4

CT Angiogram Additional Time Secondary · Same day

Additional time required for CT angiogram after standard of care imaging

Group	Value	95% CI
Additional Time Required for CT Angiogram	8	± 4.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patient With AVM Requiring Radiotherapy

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (9 terms — click to expand)

Reaction	System	Patient With AVM Requiring…
urine discoloration	Renal and urinary disorders	—
Neck pain	Musculoskeletal and connective tissue disorders	—
Pain	General disorders	—
Edema limbs	General disorders	—
Hematoma	Vascular disorders	—
Dysarthria	Nervous system disorders	—
fatigue	General disorders	—
nausea	Gastrointestinal disorders	—
blurred vision	Eye disorders	—

Data from ClinicalTrials.gov NCT03559556 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.