4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies (4D-FLOW)
Primary Purpose
Cerebro-vascular Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pilot MRI program
MRI with 4D Flow sequence
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebro-vascular Disease
Eligibility Criteria
Inclusion Criteria:
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
Experimental subjects:
- Absence of known cerebral or arterial pathology. Absence of MR contraindication
- 18 years old or more
Exclusion Criteria:
- 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
- Subjects deprived of freedom by court order or administration staff
- Major Subjects protected by the law
- Known Renal insufficiency
Sites / Locations
- Centre Hospitalier Sainte-Anne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Patients
Arm Description
Pilot subjects
Patients with an intracranial disorder or needing a supraaortic trunk MRA
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Speed measurement (m/s) of velocitymeasured in the crossection of vessels.
Measures of speeds
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.)
Full Information
NCT ID
NCT02602951
First Posted
October 6, 2015
Last Updated
October 18, 2017
Sponsor
Centre Hospitalier St Anne
Collaborators
General Electric
1. Study Identification
Unique Protocol Identification Number
NCT02602951
Brief Title
4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
Acronym
4D-FLOW
Official Title
4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 17, 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne
Collaborators
General Electric
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebro-vascular Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Pilot subjects
Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with an intracranial disorder or needing a supraaortic trunk MRA
Intervention Type
Other
Intervention Name(s)
Pilot MRI program
Intervention Description
Pilot MRI program
Intervention Type
Other
Intervention Name(s)
MRI with 4D Flow sequence
Intervention Description
MRI with 4D Flow sequence
Primary Outcome Measure Information:
Title
Number of patients presenting linear flow conditions assessed by the visual analysis of computed streamlines visualisation
Description
Flow tracking (clinical utility on the basis of qualitative criteria).
Time Frame
through study completion, an average of 12 months
Secondary Outcome Measure Information:
Title
Speed measurement (m/s) of velocitymeasured in the crossection of vessels.
Description
Measures of speeds
Time Frame
through study completion, an average of 12 months
Title
Flow aliasing within the vessels.
Description
criteria for image Quality (Image quality will be centered on the presence or absence of flow aliasing within the vessels.)
Time Frame
through study completion, an average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Experimental subjects:
Absence of known cerebral or arterial pathology. Absence of MR contraindication
18 years old or more
Exclusion Criteria:
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
Subjects deprived of freedom by court order or administration staff
Major Subjects protected by the law
Known Renal insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myriam EDJLALI, MD
Organizational Affiliation
Centre Hospitalier Sainte-Anne
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Sainte-Anne
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
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