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

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ClinicalTrials.gov Identifier: NCT03995823
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
Medical Scientific Fund of the Mayor of Vienna
Information provided by (Responsible Party):
Josa M Frischer, MD, PhD, Medical University of Vienna

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.

Condition or disease
Cerebral Arteriovenous Malformation

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MRI Evaluation of Nidus Occlusion After Gamma Knife Radiosurgery of Cerebral Arteriovenous Malformations - A Prospective Preliminary Study
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022





Primary Outcome Measures :
  1. Post radiosurgical AVM nidus obliteration on MRI [ Time Frame: The MRI examination will be performed 2 years after Gamma Knife treatment. ]
    Sensitivity and specificity of MRI/MRA evaluated by catheter angiography

  2. Post radiosurgical AVM nidus obliteration on DSA [ Time Frame: DSA will be performed within 2 months after MRI/MRA ]
    Reference method for evaluation of sensitivity and specificity of MRI/MRA



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • Patients must undergo or have undergone Gamma Knife radiosurgery due to cerebral AVM
  • For inclusion patients must have their two-year follow-up MRI exam within the duration of study
  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995823


Contacts
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Contact: Josa M Frischer, MD, PhD 0114314040045510 josa.frischer@meduniwien.ac.at
Contact: Dorian Hirschmann, MD 0114314040025800 dorian.hirschmann@meduniwien.ac.at

Locations
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Austria
Department of Neurosurgery, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Josa M Frischer, MD, PhD    004314040045510    josa.frischer@meduniwien.ac.at   
Contact: Dorian Hirschmann, MD    00436505549670    dorian.hirschmann@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Medical Scientific Fund of the Mayor of Vienna

Publications:

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Responsible Party: Josa M Frischer, MD, PhD, Assoc.Prof.Priv.Doz.Dr.PhD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03995823    
Other Study ID Numbers: 1497/2018
18096 ( Other Grant/Funding Number: Medical Scientific Fund of the Mayor of Vienna )
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Josa M Frischer, MD, PhD, Medical University of Vienna:
arteriovenous malformation
MRI
DSA
Gamma Knife
Additional relevant MeSH terms:
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Hemangioma
Intracranial Arteriovenous Malformations
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Vascular Malformations
Nervous System Malformations
Intracranial Arterial Diseases