Cerebro-vascular Disease4D-FLOWNCT02602951
4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
A study testing Pilot MRI program and MRI with 4D Flow sequence in people with Cerebro-vascular Disease, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebro-vascular Disease
- What is being tested?
- Pilot MRI program and MRI with 4D Flow sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2015to Mar 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Patient of 18 years old and more
- Patient reffered to the imaging department for a MRI for the exploration of a cervical or intracranial vascular disease (cervical stenosis, arterio-venous malformation)
- Patient whose MRI requires an injection of gadolinium
- Patient with insurance
- Informed consent
Show all 9Show fewer
- Experimental subjects:
- Absence of known cerebral or arterial pathology. Absence of MR contraindication
- 18 years old or more
Who cannot join
- Emergency situation: patient in an urgent situation care
- Contraindications to the administration of Gadolinium (patients only)
- Contraindications to MRI :
- cardiac or neuronal stimulating device, ferromagnetic surgical Clips, cochlear Implants, metallic intraocular Foreign bodies or in the nervous system
- Claustrophobia
- Pregnant Women
Show all 9Show fewer
- Subjects deprived of freedom by court order or administration staff
- Major Subjects protected by the law
- Known Renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies by providing hemodynamical measures not yet accessible in clinical settings.
In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.
Read the detailed description
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies (arterio-venous deformations, cervical or intra-cranial stenoses, intra-cranial aneurysms) by providing hemodynamical measures not yet accessible in clinical settings.
In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.
STUDY HYPOTHESIS \& AIMS The investilgators hypothesized that, once optimized for brain and cervical acquisition, 4D flow MRA will provides quantitative information not available with other routinely available dynamic MR sequences. The main goal of this study is to demonstrate the feasibility of a non-invasive evaluation of hemodynamics (quantitative speed measurements and flow tracking) in neuro applications using the 4D Flow prototype. The secondary goal is to compare parameters derived from 4D Flow prototype using two post-processing pipelines.
4D Flow images will be compared to other available hemodynamic information obtained as part of the routine clinical care in order to assess whether additional clinically relevant information can be extracted.
The study of the arterio-venous deformations and the study of the supraaortic trunks require the realization of MRI sequences with injection of Gd during a clinical protocol of routine. The sequence added at the end of protocol does not modify the injection with clinical purpose.
- Conditions
- Cerebro-vascular Disease
- Being tested
- Pilot MRI program, MRI with 4D Flow sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot MRI programOther
Pilot MRI program
MRI with 4D Flow sequenceOther
MRI with 4D Flow sequence
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Pilot subjects Receives: Other: Pilot MRI program |
| Patients | Experimental | Patients with an intracranial disorder or needing a supraaortic trunk MRA Receives: Other: MRI with 4D Flow sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients presenting linear flow conditions assessed by the visual analysis of computed streamlines visualisation
Flow tracking (clinical utility on the basis of qualitative criteria).
Measured: through study completion, an average of 12 months
Secondary outcomes (2)
Speed measurement (m/s) of velocitymeasured in the crossection of vessels.
Measures of speeds
Measured: through study completion, an average of 12 months
Flow aliasing within the vessels.
criteria for image Quality (Image quality will be centered on the presence or absence of flow aliasing within the vessels.)
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start17 Nov 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebro-vascular DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric
- Responsible party
- Sponsor
- Investigators
- Myriam EDJLALI, MD, Study director, Centre Hospitalier Sainte-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602951
- Sponsor's protocol ID
- D15-P006
- Acronym
- 4D-FLOW
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
- ClinicalTrials.gov ID
- NCT02602951
- Acronym / sponsor ID
- 4D-FLOW / D15-P006
- Conditions
- Cerebro-vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- General Electric
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Nov 2015 (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.
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies by providing hemodynamical measures not yet accessible in clinical settings.
In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.
Detailed description
The dynamic angio-MR sequences with injection of contrast (CE ARM) allow the study of the vascular anatomy. These sequences, widely used in clinical routine have shown their utility, in particular in the detection of the cerebrovascular diseases. The 4D flow MR sequences allow to quantify arterial parameters such as the speed of the circulating flow. By allowing an anatomical analysis and a functional analysis of quantitative parameters, 4D flow MR sequences could replace 1/ the currently used dynamic MRA sequences that are less precise in term of spatial and temporal resolution; 2/ the invasive exploration by DSA for the detection of vascular lesion and complete the exploration of the cervico-encephalic vascular pathologies (arterio-venous deformations, cervical or intra-cranial stenoses, intra-cranial aneurysms) by providing hemodynamical measures not yet accessible in clinical settings.
In this context, the aim of the study is to evaluate the feasibility and the clinical usefulness of this 4D Flow technique to image brain vascular disorders including steno occlusive disorders. The evaluation will include several steps: 1/ optimization of acquisition parameters for the cranio-cervical arteries; 2/ comparison of two strategies for the post-processing 3/ feasibility for imaging of brain vascular disorders.
STUDY HYPOTHESIS \& AIMS The investilgators hypothesized that, once optimized for brain and cervical acquisition, 4D flow MRA will provides quantitative information not available with other routinely available dynamic MR sequences. The main goal of this study is to demonstrate the feasibility of a non-invasive evaluation of hemodynamics (quantitative speed measurements and flow tracking) in neuro applications using the 4D Flow prototype. The secondary goal is to compare parameters derived from 4D Flow prototype using two post-processing pipelines.
4D Flow images will be compared to other available hemodynamic information obtained as part of the routine clinical care in order to assess whether additional clinically relevant information can be extracted.
The study of the arterio-venous deformations and the study of the supraaortic trunks require the realization of MRI sequences with injection of Gd during a clinical protocol of routine. The sequence added at the end of protocol does not modify the injection with clinical purpose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Pilot MRI programPilot subjects |
| Patients | Experimental | Other: MRI with 4D Flow sequencePatients with an intracranial disorder or needing a supraaortic trunk MRA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient of 18 years old and more
- Patient reffered to the imaging department for a MRI for the exploration of a cervical or intracranial vascular disease (cervical stenosis, arterio-venous malformation)
- Patient whose MRI requires an injection of gadolinium
- Patient with insurance
- Informed consent
Key exclusion criteria (9 listed)
- Emergency situation: patient in an urgent situation care
- Contraindications to the administration of Gadolinium (patients only)
- Contraindications to MRI :
- cardiac or neuronal stimulating device, ferromagnetic surgical Clips, cochlear Implants, metallic intraocular Foreign bodies or in the nervous system
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot MRI programPilot MRI program | Other | Control |
| MRI with 4D Flow sequenceMRI with 4D Flow sequence | Other | Patients |
Primary outcome
Number of patients presenting linear flow conditions assessed by the visual analysis of computed streamlines visualisation
Time frame: through study completion, an average of 12 months
Flow tracking (clinical utility on the basis of qualitative criteria).
2 secondary outcomes
Speed measurement (m/s) of velocitymeasured in the crossection of vessels.
Time frame: through study completion, an average of 12 months
Flow aliasing within the vessels.
Time frame: through study completion, an average of 12 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 20 Oct 2017.
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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.
Myriam EDJLALI, MD study director
Centre Hospitalier Sainte-Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot MRI program and MRI with 4D Flow sequence in people with Cerebro-vascular Disease, run by Centre Hospitalier St Anne 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 9 inclusion and 9 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 20 Oct 2017. 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?
Number of patients presenting linear flow conditions assessed by the visual analysis of computed streamlines visualisation (time frame: through study completion, an average of 12 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 20 Oct 2017.