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Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries (IRM-de-FLUX)

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ClinicalTrials.gov Identifier: NCT02829190
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements data with morphological images.

Even if the anatomy of the external carotid artery is well known, data obtained through Phase contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive surgery.

The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular flow characterization branches of the external carotid artery in healthy patients and in pathological cases.


Condition or disease Intervention/treatment Phase
Carotid Artery, External Device: Magnetic Resonance Imaging (MRI), Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases
Actual Study Start Date : January 6, 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Healthy volunteers
Magnetic Resonance Imaging (MRI)
Device: Magnetic Resonance Imaging (MRI),
Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods

Experimental: Patients treated by radiotherapy
Magnetic Resonance Imaging (MRI)
Device: Magnetic Resonance Imaging (MRI),
Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods

Experimental: Patients treated by embolization
Magnetic Resonance Imaging (MRI)
Device: Magnetic Resonance Imaging (MRI),
Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods

Experimental: Patient operated on with free flap
Magnetic Resonance Imaging (MRI)
Device: Magnetic Resonance Imaging (MRI),
Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods




Primary Outcome Measures :
  1. measurability of flow 1 [ Time Frame: 1 hour ]
    flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the maximum speed

  2. measurability of flow 2 [ Time Frame: 1 hour ]
    flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the minimum speed

  3. measurability of flow 3 [ Time Frame: 1 hour ]
    flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the average speed

  4. measurability of flow 4 [ Time Frame: 1 hour ]
    flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the maximum flow rates

  5. measurability of flow 5 [ Time Frame: 1 hour ]
    flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the minimal flow rates

  6. measurability of flow 6 [ Time Frame: 1 hour ]
    flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the medium flow rates



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • group 1 : healthy volunteer
  • group 2 : X-Ray treatment antecedent (at least 50 grays and older than one year)
  • group 3 : antecedent of embolization of branches of external carotid artery
  • group 4 : antecedent of muscular free flap surgery (older than one month)
  • free and informed consent

Exclusion Criteria:

  • group 1 : facial pathology, antecedent of facial injury, antecedent of X-Ray treatment in head and neck localisation, antecedent of head and neck cancer
  • group 2 : antecedent of surgery for head and neck cancer or for vascular disease
  • group 3 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of X-Ray treatment.
  • group 4 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of X-Ray treatment or embolization
  • patient with guardianship or trusteeship
  • MRI cons-indications
  • pregnancy and lactation

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): NCT02829190


Contacts
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Contact: Stéphanie DAKPE, MD 03 22 08 90 50 ext 033 dakpe.stephanie@chu-amiens.fr

Locations
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France
Departement of Maxillo-Facial Surgery, Amiens University Hospital Recruiting
Amiens, Picardie, France, 80054
Contact: Bernard DEVAUCHELLE, MD, phD    0033 3 22 08 90 50    devauchelle.bernard@chu-amiens.fr   
Sub-Investigator: Stéphanie DAKPE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Bernard DEVAUCHELLE, MD, phD Amiens University Hospital

Publications:
Dakpé, S., 2007. Allotransplantation faciale composite: reflexion à propos de l'intégration de trois greffons expérimentaux.Université Paris XI.
Testelin, Sylvie, 2000. Incidence du flux microvasculaire sur le comportement des tissus transplantés. Exploration par vélocimétrie doppler laser. Université de Picardie Jules Verne-Amiens.

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02829190     History of Changes
Other Study ID Numbers: PI2013_843_0006
2013-A00319-36 ( Other Identifier: ID-RCB )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
External carotid artery
Facial artery
Lingual artery
Superior thyroid artery
Internal maxillary artery
Phase-contrast MRI
Rate of flow
Superficial temporal artery