MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
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
- 1
- 主要终点
- Composite criteria
研究概览
简要总结
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU
详细描述
Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Aged more than 18 years
- •Not postmenopausal
- •Having one or two symptomatic fibroid with size < 15cm.
- •Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
- •Normal cervicovaginal smear performed within 2 years prior to inclusion
- •Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
- •SSS score on UFS-Qol ≥ 10
- •Signed informed consent prior to any study related procedure
- •With a medical insurance
排除标准
- •Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
- •Presence or suspicious of pelvic malignant tumor
- •Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb <10g/dl)
- •Pregnant or lactating woman
- •Small submucous myoma accessible for hysteroscopic treatment.
- •Active pelvic infection
- •Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
研究组 & 干预措施
Myoma elastography
The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured.
The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam.
干预措施: Myoma elastography (Device)
结局指标
主要结局
Composite criteria
时间窗: Baseline
Composite criteria measured from: * myoma stiffness (measured by Resoundant system) and * ablathermy efficiency.
次要结局
- inter-observer reproducibility(Baseline)
- leiomyoma stiffness measured by ARFI-US(Baseline)
- leiomyoma stiffness measured by Resoundant system(Baseline)
- clinical efficiency(month 6)
- leiomyoma perfusion(Month 6)
- leiomyoma T2 signal(Month 6)