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Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02896881
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

In previous studies exploring specific sequences of MRI (susceptibility weighted imaging (SWI) and arterial spin labeling (ASL)), the investigators have shown the great sensibility of these MRI sequences to detect arteriovenous shunts, compared to angiography imaging (static or dynamic).

This prospective study aims to compare multisequence MRI to brain arteriography imaging in patients undergoing brain arteriovenous malformations embolization.


Condition or disease
Brain Arteriovenous Malformations

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Interest of New MRI Sequences After Embolization of Brain Arteriovenous Malformations (MAV-IRM)
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. sensitivity of multisequence MRI to detect a residual arteriovenous malformation after embolization [ Time Frame: within 3 months after embolization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with brain Arteriovenous Malformations and embolization treatment scheduled.
Criteria

Inclusion Criteria:

  • Patient ≥ 18 years old
  • with brain Arteriovenous Malformations
  • embolization treatment scheduled

Exclusion Criteria:

  • patient's refusal to participate in the study
  • contraindication to undergo MRI examination
  • patient under legal protection

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): NCT02896881


Contacts
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Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Locations
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France
Fondation Opthalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Raphaël BLANC       rblanc@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Raphaël BLANC, MD Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02896881    
Other Study ID Numbers: RBC_2016_7
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms