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

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 3

Conditions: Carotid Artery, External

Treatments: Device: Magnetic Resonance Imaging (MRI),

Study type: Interventional

Funder types: Other

Identifiers

NCT02829190

2013-A00319-36 (Other Identifier)

PI2013_843_0006

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Healthy volunteers

Experimental group

Description:

Magnetic Resonance Imaging (MRI)

Treatment:

Device: Magnetic Resonance Imaging (MRI),

Patients treated by radiotherapy

Experimental group

Description:

Magnetic Resonance Imaging (MRI)

Treatment:

Device: Magnetic Resonance Imaging (MRI),

Patients treated by embolization

Experimental group

Description:

Magnetic Resonance Imaging (MRI)

Treatment:

Device: Magnetic Resonance Imaging (MRI),

Patient operated on with free flap

Experimental group

Description:

Magnetic Resonance Imaging (MRI)

Treatment:

Device: Magnetic Resonance Imaging (MRI),