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

NCT ID: NCT02829190

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-06

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Carotid Artery, External

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Magnetic Resonance Imaging (MRI)

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI),

Intervention Type DEVICE

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

Patients treated by radiotherapy

Magnetic Resonance Imaging (MRI)

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI),

Intervention Type DEVICE

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

Patients treated by embolization

Magnetic Resonance Imaging (MRI)

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI),

Intervention Type DEVICE

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

Patient operated on with free flap

Magnetic Resonance Imaging (MRI)

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI),

Intervention Type DEVICE

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

Interventions

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Magnetic Resonance Imaging (MRI),

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard DEVAUCHELLE, MD, phD

Role: PRINCIPAL_INVESTIGATOR

Amiens University Hospital

Locations

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Departement of Maxillo-Facial Surgery, Amiens University Hospital

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphanie DAKPE, MD

Role: CONTACT

03 22 08 90 50 ext. 033

Facility Contacts

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Bernard DEVAUCHELLE, MD, phD

Role: primary

0033 3 22 08 90 50

References

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Reference Type BACKGROUND
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Yim PJ, Tilara A, Nosher JL. The paradoxical flow hypothesis of the carotid artery: supporting evidence from phase-contrast magnetic resonance imaging. J Stroke Cerebrovasc Dis. 2008 Mar-Apr;17(2):101-8. doi: 10.1016/j.jstrokecerebrovasdis.2007.10.004.

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Reference Type BACKGROUND
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Other Identifiers

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2013-A00319-36

Identifier Type: OTHER

Identifier Source: secondary_id

PI2013_843_0006

Identifier Type: -

Identifier Source: org_study_id

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