Neurovascular DiseasesNCE MRANCT01566903
Neurovascular Non Contrast-Enhanced MR Angiography at 3T
An observational study of Neurovascular Diseases, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurovascular Diseases
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2012to 22 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neurovascular diseases
Who may be able to join
- Men and women over 18 years
- Any adult patient known or clinically suspect to present a neurovascular disease (arterial stenosis ou arteriovenous malformations), the assessment of which requires an MRA or patient having an arteriovenous malformation for which treatment by embolization or radiosurgery is indicated multidisciplinary meeting and followed in the ordinary course of this treatment
- Patient able of accepting protocol information
- Patient who received information about the protocol and had not expressed its opposition to participate
Who cannot join
- A contraindication to MRI, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
- Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection
- Hemodynamically unstability, acute respiratory failure, a precarious condition or a need for continuous monitoring incompatible with the constraints of MR imaging
- Patient with severe kidney with Glomerular Filtration rate < 30 ml/min
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Neurovascular Diseases
- Keywords
- arterial stenosis, arteriovenous malformations, Post-treatment follow-up
- Medical subject headings
- Arteriovenous Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| arteriovenous malformations | Not described | |
| Arterial stenosis | Not described | |
| Post-treatment follow-up | Patient with an arteriovenous malformation for which treatment by embolization or radiosurgery is indicated |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reading grid assessing the image quality
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
Measured: 54 months
Secondary outcomes (2)
An evaluation grid classifying the main pathological findings
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
Measured: 54 months
An evaluation of the performance of new sequences
Evaluation of the performance of new sequences to quantify hemodynamic parameters in arteriovenous shunts and detect anatomical and hemodynamic changes after treatment with partial embolization or radiosurgery.
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study start5 Jun 2012
- Primary completion22 Nov 2016
- Study completion22 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-yves gauvrit, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566903
- Sponsor's protocol ID
- 2011-A01258-33
- Other IDs
- LOC/11-19
- Acronym
- NCE MRA
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2012
- Last updated
- 17 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Dynamic Non Contrast-enhanced MR Angiography in the Exploration of Neurovascular Diseases
- ClinicalTrials.gov ID
- NCT01566903
- Acronym / sponsor ID
- NCE MRA / 2011-A01258-33
- Conditions
- Neurovascular Diseases
- Keywords
- arterial stenosis, arteriovenous malformations, Post-treatment follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2012 (actual)
- Primary completion
- 22 Nov 2016 (actual)
- Study completion
- 22 Nov 2016 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| arteriovenous malformations | – | – |
| Arterial stenosis | – | – |
| Post-treatment follow-up | – | –Patient with an arteriovenous malformation for which treatment by embolization or radiosurgery is indicated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neurovascular diseases
Key inclusion criteria (4 listed)
- Men and women over 18 years
- Any adult patient known or clinically suspect to present a neurovascular disease (arterial stenosis ou arteriovenous malformations), the assessment of which requires an MRA or patient having an arteriovenous malformation for which treatment by embolization or radiosurgery is indicated multidisciplinary meeting and followed in the ordinary course of this treatment
- Patient able of accepting protocol information
- Patient who received information about the protocol and had not expressed its opposition to participate
Key exclusion criteria (5 listed)
- A contraindication to MRI, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
- Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection
- Hemodynamically unstability, acute respiratory failure, a precarious condition or a need for continuous monitoring incompatible with the constraints of MR imaging
- Patient with severe kidney with Glomerular Filtration rate < 30 ml/min
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A reading grid assessing the image quality
Time frame: 54 months
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
2 secondary outcomes
An evaluation grid classifying the main pathological findings
Time frame: 54 months
An evaluation of the performance of new sequences
Time frame: 54 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean-yves gauvrit principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurovascular Diseases, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A reading grid assessing the image quality (time frame: 54 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.