Neurovascular Non Contrast-Enhanced MR Angiography at 3T (NCE MRA)
|First Received Date ICMJE||March 23, 2012|
|Last Updated Date||August 5, 2013|
|Start Date ICMJE||June 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||A reading grid assessing the image quality [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Qualitative and quantitative evaluation of image quality :
This analysis will be performed using a reading grid assessing the image quality (signal to noise ratio, motion artefacts, artefacts other than motion) and identifying the vessels visualized
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01566903 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||An evaluation grid classifying the main pathological findings [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Assessment of diagnosis performance of the nem NCE MRA sequences :
This assessment will be performed using an evaluation grid classifying the main pathological findings, ie arterial stenosis or arteriovenous shunts and assessing their extent
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Neurovascular Non Contrast-Enhanced MR Angiography at 3T|
|Official Title ICMJE||Morphological and Dynamic Non Contrast-enhanced MR Angiography in the Exploration of Neurovascular Diseases|
MR angiography (MRA) has become essential in the treatment of neurovascular diseases, including ischemic stroke - the first cause of disability in occidental countries, vascular malformations such as aneurysms, arteriovenous fistulas and malformations, whose treatments are improving year after year.
MRA is an alternative to digital substracted angiography (DSA), circumventing th use of endovascular catheterism, irradiation and injection of iodinated contrast agent. Contrast-Enhanced MRA (CE-MRA) with gadolinium injection is currently the reference standard for vascular MR exploration but still presents many limitations inherent to the injection of contrast medium. Hence, the synchronization of the acquisition with bolus contrast injection limits the improvement of spatial and temporal resolutions and requires an accurate synchronization of the acquisition with the arrival of the bolus.
Moreover, the acquisition can be repeated as required as it does not require any contrast injection.
Besides, the increase in nephrogenic systematic fibrosis clinical cases, which would be secondary to gadolinium chelates injection, in patients with chronic renal insufficiency has restricted the use of CE-MRA. More than 500 cases were described to date in the world.
Its occurrence is currently estimated around 4 % for patients in terminal chronic renal insufficiency and its mortality around 30 %.
According to the recommendations of AFSSAPS from August, 2007, two gadolinium contrast agent (Gadodiamide-OMNISCAN *, General Electric HealthCare and Gadopentetate Dimeglumine-MAGNEVIST *, Bayer HealthCare) are contraindicated if the glomerular filtration rate is lower than 30 ml/mn.
Non-contrast enhanced MR angiography (NCE MRA) techniques have been proposed to provide complete and non-invasive investigation of the vasculature, thus offering patients with chronic renal insufficiency, as well as pregnant or nursing women a surrogate with no side effects.
Moreover, the use of high field (3T) MR imaging offers improved signal to noise ratio. Combined with the use of phased array coils and parallel imaging, new NCE MRA sequences can achieve juxta-millimeter isotropic spatial resolution and temporal resolution of about 50 ms close to those of cerebral DSA.
These sequences allow a joint hemodynamical and morphological assessment of lesions, both at the cervical and cerebral levels, whether at diagnosis or during patient follow-up
The main objective is to evaluate the quality of the NCE images obtained in the exploration of neurovascular diseases, at the cervical and cerebral levels.
The secondary objective is to compare the NCE MRA sequences with the CE MRA sequences used in the clinical routine.
By circumventing the limitation to short bolus duration synchronization, the new dynamic sequences have the potential to achieve higher temporal resolution without compromising spatial resolution. Arteries and arteriovenous shunts may be more precisely identified and, due to a better visibility of small vessels allow a more accurate dynamic analysis.
Finally, the sequence being derived from arterial spin labeling, and differing from time of flight or phase contrast sequences, should allow for an exploration less dependent on the vascular geometry with better anatomical analysis. For example, the tendency to overestimate arterial stenoses could be reduced.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Patients with neurovascular diseases
|Condition ICMJE||Neurovascular Diseases|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||70|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||France|
|NCT Number ICMJE||NCT01566903|
|Other Study ID Numbers ICMJE||2011-A01258-33, LOC/11-19|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Rennes University Hospital|
|Study Sponsor ICMJE||Rennes University Hospital|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Rennes University Hospital|
|Verification Date||August 2013|
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