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

NCT03559556 | Completed Early Phase 1 Results

• 1 other identifier: STU 042018-100
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arteriovenous Malformations

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• CT Angiogram Additional Time

  Same day

Study Arms (1)

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.

Other: CT angiography

Interventions

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.

Patient with AVM requiring radiotherapy

Eligibility Criteria

• Age: 10 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Robert Timmerman
• Organization: University of Texas Southwestern Medical Center

robert.timmerman@utsouthwestern.edu

214-645-7637

Study Officials

• Robert Timmerman, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Neurosurgeon who contoured AVM nidus using interventional cerebral arteriography.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 18, 2018
• Study Start: July 25, 2019
• Primary Completion: September 10, 2021
• Study Completion: June 24, 2024
• Last Updated: October 15, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-09

Locations

US (1)