Menu
Recruiting NCT02829190

Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries

Phase III Interventional Carotid Artery, External

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Imaging (MRI),.
Who it may be relevant to
Registry conditions: Carotid Artery, External. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases

Overview

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.

Interventions

  • Device Magnetic Resonance Imaging (MRI),
    Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods

Primary outcome measures

  • measurability of flow 1 [Time frame: 1 hour]
  • measurability of flow 2 [Time frame: 1 hour]
  • measurability of flow 3 [Time frame: 1 hour]
  • measurability of flow 4 [Time frame: 1 hour]
  • measurability of flow 5 [Time frame: 1 hour]
  • measurability of flow 6 [Time frame: 1 hour]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Departement of Maxillo-Facial Surgery, Amiens University Hospital — Amiens

Publications

  • Baledent O, Fin L, Khuoy L, Ambarki K, Gauvin AC, Gondry-Jouet C, Meyer ME. Brain hydrodynamics study by phase-contrast magnetic resonance imaging and transcranial color doppler. J Magn Reson Imaging. 2006 Nov;24(5):995-1004. doi: 10.1002/jmri.20722. PMID 17024656
  • Cadenat H, Barthelemy R, Combelles R, Fabie M, Maneaud M. [Importance of mandibular vascularization in maxillofacial surgery]. Rev Stomatol Chir Maxillofac. 1972 Jan-Feb;73(1):60-5. No abstract available. French. PMID 4504634
  • Castelli WA, Nasjleti CE, Diaz-Perez R. Interruption of the arterial inferior alveolar flow and its effects on mandibular collateral circulation and dental tissues. J Dent Res. 1975 Jul-Aug;54(4):708-15. doi: 10.1177/00220345750540040301. PMID 808564
  • Combelles R, Manelfe C, Hugot B, Pasturel J, Barthelemy R, Fabie M, Cadenat H. [Selective catherization of the external carotid in stomatology]. Rev Odontostomatol Midi Fr. 1974;32(1):19-37. No abstract available. French. PMID 4438882
  • Dakpé, S., 2007. Allotransplantation faciale composite: reflexion à propos de l'intégration de trois greffons expérimentaux.Université Paris XI.
  • Decorato I, Kharboutly Z, Vassallo T, Penrose J, Legallais C, Salsac AV. Numerical simulation of the fluid structure interactions in a compliant patient-specific arteriovenous fistula. Int J Numer Method Biomed Eng. 2014 Feb;30(2):143-59. doi: 10.1002/cnm.2595. Epub 2013 Nov 5. PMID 24493402
  • d'Hauthuille C, Testelin S, Moure C, Gbaguidi C, Devauchelle B. [Mandibular osteoradionecrosis. Part II: efficiency of revascularization surgery]. Rev Stomatol Chir Maxillofac. 2008 Nov;109(5):296-300. doi: 10.1016/j.stomax.2007.12.009. Epub 2008 Jun 4. French. PMID 18534648
  • Frydrychowicz A, Francois CJ, Turski PA. Four-dimensional phase contrast magnetic resonance angiography: potential clinical applications. Eur J Radiol. 2011 Oct;80(1):24-35. doi: 10.1016/j.ejrad.2011.01.094. Epub 2011 Feb 17. PMID 21333479

Identifiers

NCT: NCT02829190 · PI2013_843_0006 · 2013-A00319-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗