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临床试验/NCT02386137
NCT02386137已完成不适用

Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Ablathermy efficiency.

研究概览

简要总结

Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. Despite the benefits, it should be recognized that MR HIFU ablation does not always yield good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (NPV) ratio (ie, NPV divided by fibroid volume).

The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine fibroid treatment by MR-HIFU.

详细描述

Preprocedural predictors of treatment efficacy will be useful for excluding in advance patients who would not benefit from this treatment, thereby contributing to improved overall clinical outcomes. During ablathermy treatment lost of energy depend of tissue perfusion and thermic diffusion while energy laying depend of tissue absorption coefficient. Study these parameters before treatment could bring important information to the treatment difficulty and its efficacy. The investigators will study and compare fibroid perfusion with dynamic contrast-enhanced magnetic resonance imaging and contrast-enhanced ultrasound (CEUS). CEUS will be performed with contrast agent (SONOVUE). Thermic diffusion could be linked with fibroid stiffness. Fibroid stiffness will be quantified with velocity of shear wave measured by acoustic radiation force impulse (ARFI). Tissue absorption coefficient is correlated with the architecture and the cellularity of the tissue so the investigators think that apparent diffusion coefficient (computed with diffusion weighted imaging) could be correlated with ablathermy efficiency and other intra procedural thermal parameters.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Aged more than 18 years
  • Not postmenopausal
  • Having one or two symptomatic fibroid with size < 15cm.
  • Symptoms Severity Score (SSS) score on Uterine Fibroid Symptoms related Quality of Life (UFS-Qol) ≥ 10
  • Signed informed consent prior to any study related procedure
  • With a medical insurance

排除标准

  • Contraindicated to MR examination, SONOVUE and gadolinium contrast injection (pregnancy etc..).
  • Presence or suspicious of pelvic malignant tumor

研究组 & 干预措施

Patient

Experimental

Woman aged more than 18 years having one or two symptomatic fibroid with size < 15cm.

干预措施: Contrast-enhancement ultrasound with Sonovue (Device)

结局指标

主要结局

Ablathermy efficiency.

时间窗: 2 months after inclusion

necrosis tumor volume / total volume ratio

次要结局

  • Thermal parameters(2 months after inclusion)
  • Fibroid signal intensity ratio on T2.(At inclusion and 2 months after inclusion)
  • Fibroids perfusion data computed with MR perfusion(At inclusion)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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