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4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies (4D-FLOW)

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ClinicalTrials.gov Identifier: NCT02602951
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : October 20, 2017
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Centre Hospitalier St Anne

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.


Condition or disease Intervention/treatment Phase
Cerebro-vascular Disease Other: Pilot MRI program Other: MRI with 4D Flow sequence Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
Actual Study Start Date : November 17, 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control
Pilot subjects
Other: Pilot MRI program
Pilot MRI program

Experimental: Patients
Patients with an intracranial disorder or needing a supraaortic trunk MRA
Other: MRI with 4D Flow sequence
MRI with 4D Flow sequence




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Speed measurement (m/s) of velocitymeasured in the crossection of vessels. [ Time Frame: through study completion, an average of 12 months ]
    Measures of speeds

  2. Flow aliasing within the vessels. [ Time Frame: through study completion, an average of 12 months ]
    criteria for image Quality (Image quality will be centered on the presence or absence of flow aliasing within the vessels.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602951


Locations
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France
Centre Hospitalier Sainte-Anne
Paris, France, 75014
Sponsors and Collaborators
Centre Hospitalier St Anne
General Electric
Investigators
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Study Director: Myriam EDJLALI, MD Centre Hospitalier Sainte-Anne
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Responsible Party: Centre Hospitalier St Anne
ClinicalTrials.gov Identifier: NCT02602951    
Other Study ID Numbers: D15-P006
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases