Trial Outcomes & Findings for Treating Arteriovenous Malformation With Stereotactic Radiosurgery Using CT Angiography for Treatment Planning (NCT NCT03559556)

Last Updated: 2024-10-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

14 participants

Primary outcome timeframe

Same day measurements

Results posted on

2024-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient With AVM Requiring Radiotherapy n=14 Participants 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.
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Same day measurements

Population: 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

Outcome measures

Outcome measures
Measure	CT Angiogram in Addition to Standard of Care n=13 Participants Patients who received planning CT angiogram in addition to standard of care	Standard of Care n=13 Participants Standard of Care MRI and IR angiogram
Target Volume Difference Between Standard of Care vs. CT Angiogram and MRI Alone	1.1 mL Standard Deviation 2.5	1.3 mL Standard Deviation 2.4

SECONDARY outcome

Timeframe: Same day

Population: Time required for CT angiogram

Additional time required for CT angiogram after standard of care imaging

Outcome measures

Outcome measures
Measure	CT Angiogram in Addition to Standard of Care n=13 Participants Patients who received planning CT angiogram in addition to standard of care	Standard of Care Standard of Care MRI and IR angiogram
CT Angiogram Additional Time	8 Minutes Standard Deviation 4.3	—

Adverse Events

Patient With AVM Requiring Radiotherapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patient With AVM Requiring Radiotherapy n=13 participants at risk 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.
Renal and urinary disorders urine discoloration	7.7% 1/13 • Number of events 1 • 1 month
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Number of events 1 • 1 month
General disorders Pain	7.7% 1/13 • Number of events 1 • 1 month
General disorders Edema limbs	7.7% 1/13 • Number of events 1 • 1 month
Vascular disorders Hematoma	7.7% 1/13 • Number of events 1 • 1 month
Nervous system disorders Dysarthria	7.7% 1/13 • Number of events 1 • 1 month
General disorders fatigue	7.7% 1/13 • Number of events 1 • 1 month
Gastrointestinal disorders nausea	7.7% 1/13 • Number of events 1 • 1 month
Eye disorders blurred vision	7.7% 1/13 • Number of events 1 • 1 month

Additional Information

Dr. Robert Timmerman

University of Texas Southwestern Medical Center

Phone: 214-645-7637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place