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

October 18, 2017 updated by: Centre Hospitalier St Anne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Centre Hospitalier Sainte-Anne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
through study completion, an average of 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier St Anne

Collaborators

General Electric

Investigators

  • Study Director: Myriam EDJLALI, MD, Centre Hospitalier Sainte-Anne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2015

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (ESTIMATE)

November 11, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D15-P006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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