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

Phase 3

Recruiting

• Conditions: Carotid Artery, External
• Interventions: Device: Magnetic Resonance Imaging (MRI),

• Registration Number: NCT02829190
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-06
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients treated by radiotherapy	Magnetic Resonance Imaging (MRI),	Magnetic Resonance Imaging (MRI)
Patient operated on with free flap	Magnetic Resonance Imaging (MRI),	Magnetic Resonance Imaging (MRI)
Healthy volunteers	Magnetic Resonance Imaging (MRI),	Magnetic Resonance Imaging (MRI)
Patients treated by embolization	Magnetic Resonance Imaging (MRI),	Magnetic Resonance Imaging (MRI)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Departement of Maxillo-Facial Surgery, Amiens University Hospital; 🇫🇷 Amiens, Picardie, France