Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01566903
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2012-03-23
Brief Title:
Neurovascular Non Contrast-Enhanced MR Angiography at 3T
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Morphological and Dynamic Non Contrast-enhanced MR Angiography in the Exploration of Neurovascular Diseases
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NCE MRA
Brief Summary:
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 mlmn
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
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 mlmn
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
Detailed Description:
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
Secondary objectives are
to compare the NCE MRA sequences with the CE MRA sequences used in the clinical routine
to evaluate the anatomic and hemodynamic changes observable with sequences in the follow-up of patients particularly those treated with partial embolization or radiosurgery
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
The robustness of sequences allow the non-invasive monitoring of patients including it possible to monitor the hemodynamic changes after radiosurgery or embolization
Secondary objectives are
to compare the NCE MRA sequences with the CE MRA sequences used in the clinical routine
to evaluate the anatomic and hemodynamic changes observable with sequences in the follow-up of patients particularly those treated with partial embolization or radiosurgery
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
The robustness of sequences allow the non-invasive monitoring of patients including it possible to monitor the hemodynamic changes after radiosurgery or embolization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LOC11-19 | OTHER | Rennes University Hospital | None |