Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries in Normal and Pathological Cases
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- measurability of flow 4
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Healthy volunteers
Magnetic Resonance Imaging (MRI)
干预措施: Magnetic Resonance Imaging (MRI), (Device)
Patients treated by radiotherapy
Magnetic Resonance Imaging (MRI)
干预措施: Magnetic Resonance Imaging (MRI), (Device)
Patients treated by embolization
Magnetic Resonance Imaging (MRI)
干预措施: Magnetic Resonance Imaging (MRI), (Device)
Patient operated on with free flap
Magnetic Resonance Imaging (MRI)
干预措施: Magnetic Resonance Imaging (MRI), (Device)
结局指标
主要结局
measurability of flow 4
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 1 hour
flow data in the branches of external carotid artery in every 4 groups, characterized by measuring the minimal flow rates
次要结局
未报告次要终点