Cerebro-vascular Disease Clinical Trial
— 4D-FLOWOfficial title:
4D FLOW: Feasibility Study of a Sequence 4D of Flow Applied to the Cervico-encephalic Vascular Pathologies
| Verified date | October 2017 |
| Source | Centre Hospitalier St Anne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Sainte-Anne | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier St Anne | General Electric |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | through study completion, an average of 12 months | |
| Secondary | Speed measurement (m/s) of velocitymeasured in the crossection of vessels. | Measures of speeds | through study completion, an average of 12 months | |
| Secondary | 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.) | through study completion, an average of 12 months |