NCT02829190

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
18mo left

Started Jan 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2014Dec 2027

Study Start

First participant enrolled

January 6, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

13.9 years

First QC Date

December 1, 2014

Last Update Submit

May 12, 2026

Conditions

Carotid Artery, External

Keywords

External carotid arteryFacial arteryLingual arterySuperior thyroid arteryInternal maxillary arteryPhase-contrast MRIRate of flowSuperficial temporal artery

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (4)

Healthy volunteers

EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Device: Magnetic Resonance Imaging (MRI),

Patients treated by radiotherapy

EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Device: Magnetic Resonance Imaging (MRI),

Patients treated by embolization

EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Patient operated on with free flap

EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Device: Magnetic Resonance Imaging (MRI),

Interventions

Magnetic Resonance Imaging (MRI),DEVICE

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

Healthy volunteersPatient operated on with free flapPatients treated by radiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Maxillo-Facial Surgery, Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

Related Publications (21)

  • 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: 17024656BACKGROUND

  • 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: 4504634BACKGROUND

  • 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: 808564BACKGROUND

  • 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: 4438882BACKGROUND

  • Dakpé, S., 2007. Allotransplantation faciale composite: reflexion à propos de l'intégration de trois greffons expérimentaux.Université Paris XI.

    BACKGROUND

  • 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: 24493402BACKGROUND

  • 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: 18534648BACKGROUND

  • 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: 21333479BACKGROUND

  • 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.

    PMID: 17457258BACKGROUND

  • 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.

    PMID: 21413062BACKGROUND

  • 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.

    PMID: 10845282BACKGROUND

  • 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.

    PMID: 16464454BACKGROUND

  • 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.

    PMID: 20685054BACKGROUND

  • 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.

    PMID: 20097391BACKGROUND

  • 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.

    PMID: 3528245BACKGROUND

  • 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.

    PMID: 19910848BACKGROUND

  • 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.

    PMID: 8249802BACKGROUND

  • 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.

    PMID: 18701163BACKGROUND

  • Testelin, Sylvie, 2000. Incidence du flux microvasculaire sur le comportement des tissus transplantés. Exploration par vélocimétrie doppler laser. Université de Picardie Jules Verne-Amiens.

    BACKGROUND

  • 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.

    PMID: 18346653BACKGROUND

  • 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.

    PMID: 19008062BACKGROUND

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Bernard DEVAUCHELLE, MD, phD

    Amiens University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie DAKPE, MD

CONTACT

03 22 08 90 50dakpe.stephanie@chu-amiens.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2014

First Posted

July 12, 2016

Study Start

January 6, 2014

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations

FR(1)