Carotid Artery, ExternalPhase 3IRM-de-FLUXNCT02829190
Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries
A Phase 3 study testing Magnetic Resonance Imaging (MRI), in people with Carotid Artery, External, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery, External
- What is being tested?
- Magnetic Resonance Imaging (MRI),
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2014to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Departement of Maxillo-Facial Surgery, Amiens University Hospital
Amiens, Picardie, 80054
Bernard DEVAUCHELLE, MD, phD, 0033 3 22 08 90 50, devauchelle.bernard@chu-amiens.fr
Stéphanie DAKPE, MD
About this study
Official title: 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.
- Conditions
- Carotid Artery, External
- Being tested
- Magnetic Resonance Imaging (MRI),
- Keywords
- External carotid artery, Facial artery, Lingual artery, Superior thyroid artery, Internal maxillary artery, Phase-contrast MRI, Rate of flow, Superficial temporal artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI),Device
Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Magnetic Resonance Imaging (MRI) Receives: Device: Magnetic Resonance Imaging (MRI), |
| Patients treated by radiotherapy | Experimental | Magnetic Resonance Imaging (MRI) Receives: 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) Receives: Device: Magnetic Resonance Imaging (MRI), |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurability of flow 1
flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the maximum speed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start6 Jan 2014
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery, ExternalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard DEVAUCHELLE, MD, phD, Principal investigator, Amiens University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829190
- Sponsor's protocol ID
- PI2013_843_0006
- Other IDs
- 2013-A00319-36
- Acronym
- IRM-de-FLUX
- Status last verified
- May 2026
- First submitted
- 1 Dec 2014
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17024656Cadenat 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.
PubMed 4504634Castelli 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.
PubMed 808564Combelles 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.
PubMed 4438882Dakpé, 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.
PubMed 24493402d'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.
PubMed 18534648Frydrychowicz 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.
PubMed 21333479Gauvrit 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.
PubMed 17457258Herment 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.
PubMed 21413062Houseman 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.
PubMed 10845282Maurits 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.
PubMed 16464454Morita 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.
PubMed 20685054Mouton 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.
PubMed 20097391Nayler 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.
PubMed 3528245
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases
- ClinicalTrials.gov ID
- NCT02829190
- Acronym / sponsor ID
- IRM-de-FLUX / PI2013_843_0006
- Conditions
- Carotid Artery, External
- Keywords
- External carotid artery, Facial artery, Lingual artery, Superior thyroid artery, Internal maxillary artery, Phase-contrast MRI, Rate of flow, Superficial temporal artery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Device: Magnetic Resonance Imaging (MRI),Magnetic Resonance Imaging (MRI) |
| Patients treated by radiotherapy | Experimental | Device: Magnetic Resonance Imaging (MRI),Magnetic Resonance Imaging (MRI) |
| Patients treated by embolization | Experimental | –Magnetic Resonance Imaging (MRI) |
| Patient operated on with free flap | Experimental | Device: Magnetic Resonance Imaging (MRI),Magnetic Resonance Imaging (MRI) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI),Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods | Device | Healthy volunteers, Patient operated on with free flap, Patients treated by radiotherapy |
Primary outcome
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Background: PubMed 17024656Baledent 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.
- Background: PubMed 4504634Cadenat 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.
- Background: PubMed 808564Castelli 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.
- Background: PubMed 4438882Combelles 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.
- BackgroundDakpé, S., 2007. Allotransplantation faciale composite: reflexion à propos de l'intégration de trois greffons expérimentaux.Université Paris XI.
- Background: PubMed 24493402Decorato 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.
- Background: PubMed 18534648d'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.
- Background: PubMed 21333479Frydrychowicz 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.
- Background: PubMed 17457258Gauvrit 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.
- Background: PubMed 21413062Herment 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.
- Background: PubMed 10845282Houseman 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.
- Background: PubMed 16464454Maurits 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernard DEVAUCHELLE, MD, phD principal investigator
Amiens University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnetic Resonance Imaging (MRI), in people with Carotid Artery, External, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie DAKPE, MD (03 22 08 90 50 ext. 033, dakpe.stephanie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurability of flow 1 (time frame: 1 hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02829190, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.