Targeted Vessel Ablation of Type 3 Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Regional Blood volume
研究概览
简要总结
So-called type 1 and 2 uterine fibroids are well treatable with Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). The other type, type 3 fibroids, however, are known for their high perfusion and poor treatment outcome after MR-HIFU. This study proposes a new strategy to treat type 3 fibroids with MR-HIFU. Very precise, small, high-power sonications (heating points) will be used to occlude (part of) the feeding vessels of the fibroid. This deminishes the negative effect of the high perfusion and is hypothesized to transform a type 3 fibroid into a type 2 or possibly even a type 1 fibroid. Consequently, the bulk volume of the fibroid can be treated using the standard approach.
详细描述
Rationale: Uterine fibroids or leiomyomas are common benign tumors that arise from smooth muscle cells of the uterus with a prevalence ranging from 20% to 40% in reproductive aged women. Invasive treatments, such as hysterectomy and myomectomy, represent the golden standard with respect to therapy. Alternatively, uterine artery embolization is offered as a less invasive option. However, to date the only non-invasive technique is high intensity focused ultrasound (HIFU) ablation. HIFU ablation uses focused ultrasound waves to non-invasively heat and thermally ablate tissue. Combined with magnetic resonance guidance (MR-HIFU) this allows an entirely non-invasive intervention with anatomical 3D images for the planning of the treatment volume, and real-time temperature monitoring for therapeutic guidance.
A limitation of MR-HIFU is that currently not all types of uterine fibroids are treatable. With respect to MR-HIFU treatment, uterine fibroids are classified in three classes based on the signal intensity of T2-weighted MR images. While MR-HIFU has been shown to result in a reliable positive therapeutic outcome in type 1 and type 2 fibroids, the therapeutic success in type 3 fibroids has so far been limited. The current clinical consensus is that the high perfusion in type 3 fibroids, which causes the heat deposited by the HIFU to be rapidly evacuated from the treatment site, results in insufficient temperatures to induce necrosis in the fibroids. Therefore, a new treatment strategy is proposed to effectively treat type 3 fibroids with MR-HIFU.
Objective: To investigate whether it is possible to manipulate perfusion in type 3 fibroids with MR-HIFU.
Study design: Single-center, single arm, non-randomized trial. Ten patients will be treated.
Study population: Adult women with a type 3 uterine fibroid who fulfill the in- and exclusion criteria.
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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent;
- •A type 3 uterine fibroid;
- •Sufficient physical condition to undergo deep sedation;
- •Waist circumference that allows positioning on the HIFU table top inside the MR bore.
排除标准
- •Contra-indication for MRI scanning according to the hospital guidelines;
- •Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR <30 mL/min/1.73 m2);
- •Surgical clips or considerable scar tissue in the HIFU beam path;
- •A total of more than ten fibroids;
- •Post- or peri-menopausal status;
- •Fibroid size >10 cm in diameter;
- •Patient has an active pelvic infection;
- •Patient has an undiagnosed pelvic mass outside the uterus;
- •Patient who is not able to tolerate the required stationary prone position during treatment.
结局指标
主要结局
Regional Blood volume
时间窗: Three months
The main endpoint of this feasibility study is the manipulation of perfusion in the type 3 uterine fibroid and the possibly related adverse events. The perfusion will be assessed by comparing the results of dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after three months, i.e. regional blood volumes (area under the curve). Data will be analyzed using Philips IntelliSpace Portal.
Time to peak
时间窗: three months
The main endpoint of this feasibility study is the manipulation of perfusion in the type 3 uterine fibroid. The perfusion will be assessed by comparing the results of dynamic contrast-enhanced MRI (DCE-MRI) before and after treatment and after three months, i.e. the time to peak values. Data will be analyzed using Philips IntelliSpace Portal.
次要结局
- Adverse effects(Three months)
研究者
Maurice A.A.J. van den Bosch
Prof. Dr.
UMC Utrecht