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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery, External
• Intervention / Treatment: Device: Magnetic Resonance Imaging (MRI),

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Stéphanie DAKPE, MD; Phone Number: 033 03 22 08 90 50; Email: dakpe.stephanie@chu-amiens.fr

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • Recruiting
      • Departement of Maxillo-Facial Surgery, Amiens University Hospital
      • Contact: Bernard DEVAUCHELLE, MD, phD; Phone Number: 0033 3 22 08 90 50; Email: devauchelle.bernard@chu-amiens.fr
      • Sub-Investigator: Stéphanie DAKPE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurability of flow 1	flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the maximum speed	1 hour
measurability of flow 2	flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the minimum speed	1 hour
measurability of flow 3	flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the average speed	1 hour
measurability of flow 4	flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the maximum flow rates	1 hour
measurability of flow 5	flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the minimal flow rates	1 hour
measurability of flow 6	flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the medium flow rates	1 hour

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Bernard DEVAUCHELLE, MD, phD, Amiens University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Gauvrit J, Trystram D, Oppenheim C, Leclerc X. [Advanced vascular imaging techniques of supra-aortic, encephalic and medullary vessels]. J Radiol. 2007 Mar;88(3 Pt 2):472-82. doi: 10.1016/s0221-0363(07)89847-7. French.
• Herment A, Lefort M, Kachenoura N, De Cesare A, Taviani V, Graves MJ, Pellot-Barakat C, Frouin F, Mousseaux E. Automated estimation of aortic strain from steady-state free-precession and phase contrast MR images. Magn Reson Med. 2011 Apr;65(4):986-93. doi: 10.1002/mrm.22678. Epub 2010 Nov 3.
• Houseman ND, Taylor GI, Pan WR. The angiosomes of the head and neck: anatomic study and clinical applications. Plast Reconstr Surg. 2000 Jun;105(7):2287-313. doi: 10.1097/00006534-200006000-00001.
• Maurits NM, Loots GE, Veldman AE. The influence of vessel wall elasticity and peripheral resistance on the carotid artery flow wave form: a CFD model compared to in vivo ultrasound measurements. J Biomech. 2007;40(2):427-36. doi: 10.1016/j.jbiomech.2005.12.008. Epub 2006 Feb 7.
• Morita S, Suzuki K, Masukawa A, Kojima S, Hirata M, Ueno E. Identification of efferent flow in the superior vena cava and azygos vein confluence using cine phase-contrast MRI: speculation of the role of the azygos arch valves. Magn Reson Imaging. 2010 Nov;28(9):1306-10. doi: 10.1016/j.mri.2010.06.005. Epub 2010 Aug 4.
• Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.
• Nayler GL, Firmin DN, Longmore DB. Blood flow imaging by cine magnetic resonance. J Comput Assist Tomogr. 1986 Sep-Oct;10(5):715-22. doi: 10.1097/00004728-198609000-00001.
• Pomahac B, Lengele B, Ridgway EB, Matros E, Andrews BT, Cooper JS, Kutz R, Pribaz JJ. Vascular considerations in composite midfacial allotransplantation. Plast Reconstr Surg. 2010 Feb;125(2):517-522. doi: 10.1097/PRS.0b013e3181c82e6f.
• Rebergen SA, van der Wall EE, Doornbos J, de Roos A. Magnetic resonance measurement of velocity and flow: technique, validation, and cardiovascular applications. Am Heart J. 1993 Dec;126(6):1439-56. doi: 10.1016/0002-8703(93)90544-j.
• Saliou G, Baledent O, Lehmann P, Paradot G, Gondry-Jouet C, Bouzerar R, Devisme G, Theaudin M, Deramond H, Le Gars D, Meyer ME, Vallee JN. [Acute CSF changes in the mesencephalon aqueduct after subarachnoid hemorrhage as measured by PC-MRI]. J Neuroradiol. 2009 Mar;36(1):41-7. doi: 10.1016/j.neurad.2008.07.004. Epub 2008 Aug 12. French.
• Testelin, Sylvie, 2000. Incidence du flux microvasculaire sur le comportement des tissus transplantés. Exploration par vélocimétrie doppler laser. Université de Picardie Jules Verne-Amiens.
• Yim PJ, Tilara A, Nosher JL. The paradoxical flow hypothesis of the carotid artery: supporting evidence from phase-contrast magnetic resonance imaging. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):101-8. doi: 10.1016/j.jstrokecerebrovasdis.2007.10.004.
• Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2014
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (ESTIMATE): July 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: External carotid artery; Facial artery; Lingual artery; Superior thyroid artery; Internal maxillary artery; Phase-contrast MRI; Rate of flow; Superficial temporal artery
• Other Study ID Numbers: PI2013_843_0006; 2013-A00319-36 (OTHER: ID-RCB)