Recruiting

NCT Number: NCT02829190

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

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.

Recruiting

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Key information

Conditions

Carotid Artery, External

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Departement of Maxillo-Facial Surgery, Amiens University Hospital

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Bernard DEVAUCHELLE, MD, phD

CONTACT

[email protected]

0033 3 22 08 90 50

Stéphanie DAKPE, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI),

Device

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

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphanie DAKPE, MD

CONTACT

[email protected]

03 22 08 90 50 ext. 033

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: IRM-de-FLUX

Important dates

Study start: 2014
Primary completion: 2027
Study completion: 2027
First posted: Jul 12, 2016
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.