Clinical trial NCT02829190: Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries
Official title: Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
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
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: measurability of flow 1
timeFrame: 1 hour
measure: measurability of flow 2
timeFrame: 1 hour
measure: measurability of flow 3
timeFrame: 1 hour
measure: measurability of flow 4
timeFrame: 1 hour
measure: measurability of flow 5
timeFrame: 1 hour
measure: measurability of flow 6
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Departement of Maxillo-Facial Surgery, Amiens University Hospital
state: Picardie
Study officials:
affiliation: Amiens University Hospital
name: Bernard DEVAUCHELLE, MD, phD
role: PRINCIPAL_INVESTIGATOR
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