Contrast-enhanced Ultrasound (CE-US) and Magnetic Resonance Imaging (MRI): Evaluating Plaque Neovascularisation
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|ClinicalTrials.gov Identifier: NCT00677963|
Recruitment Status : Completed
First Posted : May 15, 2008
Last Update Posted : April 20, 2011
The first goal of this study is to investigate whether CE-US is able to accurately identify and quantify neovascularisation in carotid artery plaques. Since this is one of the first studies systematically evaluating the ability of ultrasound in combination with air bubbles to evaluate neovascularisation in carotid artery plaques, the examination will be performed twice with an interval of 1/2 hour on the day before surgery, thus studying the reliability of the method.
The second goal of this study is to investigate whether MRI at 3.0 T with a custom-designed 3T carotid coil, using a recently developed pulse sequence, is able to accurately identify and quantify neovascularisation. And the third goal of this study is to make an intermodality comparison of CE-US and MRI regarding their ability to identify and quantify plaque neovascularisation.
|Condition or disease||Intervention/treatment||Phase|
|Carotid Artery Stenosis Atherosclerosis||Drug: sulphur hexafluoride, gadopentate dimeglumine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contrast-enhanced Ultrasound and Magnetic Resonance Imaging for the Evaluation of Neovascularisation in Carotid Artery Plaques|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Patients with symptomatic 70-99% carotid stenosis who are operated on.
Drug: sulphur hexafluoride, gadopentate dimeglumine
CE-US, using 2 x 2.4 ml sulphur hexafluoride and MRI, using 1 x 0.2 ml/kg gadopentate dimeglumine
- Plaque neovascularization at contrast-enhanced ultrasound and MRI [ Time Frame: Cross-sectional ]
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): NCT00677963
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 6229 HX|
|Principal Investigator:||Werner H Mess, MD, PhD||Department of Clinical Neurophysiology, University Medical Center Maastricht|