Evaluation of Nidus Occlusion After Gamma Knife Radiosurgery of Cerebral Arteriovenous Malformations Using Magnetic Resonance Imaging

NCT03995823 | Completed

• 2 other identifiers: 1497/201818096
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral arteriovenous malformations (AVMs) are abnormal vessels, connecting cerebral arteries and veins. They form a bundle which is called nidus. Rupture of an AVM leads to intracranial hemorrhage often causing neurological impairment or even death. As treatment can be associated with high rates of morbidity and mortality, AVMs still remain a considerable challenge for neurosurgeons. For smaller AVMs, a well-established treatment option is non-invasive Gamma Knife radiosurgery (GKRS). GKRS uses radiation to obliterate the AVM nidus hence, eliminating the risk of hemorrhage. However, after Gamma Knife radiosurgery, occlusion of the AVM nidus takes about two years. To evaluate treatment success after GKRS, invasive digital subtraction angiography (DSA) is still the gold standard. For this procedure, patients have to undergo puncture of the femoral artery for application of a contrast media to receive adequate imaging of the cerebral arteries. In recent literature it has been discussed whether sufficient evaluation of treatment is possible with non-invasive magnetic resonance imaging (MRI). At present, it is unclear whether this method could replace the current invasive gold standard for treatment evaluation. To investigate on this issue, a few studies have compared the two methods however, only retrospective data exist. Thus, the investigators are conducting this prospective study including 50 patients with cerebral AVMs treated with GRKS to evaluate the sensitivity for nidus obliteration of MRI using DSA as a reference.

Conditions

Cerebral Arteriovenous Malformation

Keywords

arteriovenous malformation; MRI; DSA; Gamma Knife

Outcome Measures

Primary Outcomes (2)

• Post radiosurgical AVM nidus obliteration on MRI

  Sensitivity and specificity of MRI/MRA evaluated by catheter angiography

  The MRI examination will be performed 2 years after Gamma Knife treatment.

• Post radiosurgical AVM nidus obliteration on DSA

  Reference method for evaluation of sensitivity and specificity of MRI/MRA

  DSA will be performed within 2 months after MRI/MRA

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must undergo or have undergone Gamma Knife radiosurgery due to cerebral AVM at the Department of Neurosurgery, Medical University of Vienna. For inclusion patients must have their two-year follow-up MRI exam within the duration of study.

You may qualify if:

• Patients must undergo or have undergone Gamma Knife radiosurgery due to cerebral AVM
• All patients have to sign a form for participation in the study after purpose and process of the study has been explained to them.
• For patients younger than 18 years, a parent or legal guardian has to sign a form for participation after being informed about purpose and process of the study have been explained to them.

You may not qualify if:

• Patients who do not give informed consent to participate
• Patients younger than 16 years

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical Scientific Fund of the Mayor of Vienna: collaborator

Study Sites (1)

Department of Neurosurgery, Medical University of Vienna

Vienna, 1090, Austria

Location

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MeSH Terms

Conditions

Intracranial Arteriovenous Malformations; Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.Priv.Doz.Dr.PhD

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 24, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)