Hepatic and Renal Thermography Using Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Temperature standard deviation
研究概览
简要总结
Several technological challenges exist to apply Magnetic Resonance guided High Intensity Focused Ultrasound (MRgHIFU) for treatment of liver or kidney in particular challenges related to the motion of these organs. This study tests a new software to improve thermometry accuracy in mobile organs in patients with liver or kidney tumors. In the same time, the trajectory of the target in 3D is analyzed.
详细描述
Liver and kidney tumors represent a major health problem because most patients are unsuitable for curative treatment with surgery. Thus, percutaneous ablation, using radio frequency (RF), is preferred : an interstitial electrode that delivers alternative current is placed into the tissue. Consequently, the development of an accurate and completely non-invasive method based on MR guided HIFU treatment is of particular interest since the energy source is located outside the body. There is no incision. For the patient, it provides a treatment option with reduced trauma and improved quality of life, and for the society, it provides reduced hospitalization time and reduced costs.
MRgHIFU has already been tested clinically in tumors of immobilized tissues as uterine leiomyoma. However, several technological challenges exist to apply it for treatment of the liver or the kidney especially challenges related to the motions of these organs. In order to improve the therapeutic efficiency and the safety of the intervention, real time mapping of temperature and thermal dose appear to offer the best strategy to optimize such interventions and provide clinical therapy endpoints. Among imaging modalities, MRI Proton Resonance Frequency based method appears to be the ideal tool for temperature mapping.
One major drawback of PRF thermometry is its high sensitivity to motion. Therefore motion correction is necessary to use PRF thermometry in mobile organs such as the liver or kidneys. To correct artefacts generated in temperature maps by periodical organ motion, a new technique was developed in the IMF lab of Bordeaux University Hospital.
The primary outcome of this study is to evaluate the precision of multiplanar MR imaging with real time motion compensation in hepatic or renal tumour patient.
Secondary outcomes are :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver tumors treated or not : HCC, liver metastases of colorectal cancer, hepatocellular adenoma, focal and nodular hyperplasia,
- •Kidney tumors : carcinoma
- •more than 18 years old
排除标准
- •Tumours of the liver dome
- •Deprived of their liberty by court
- •Pregnant woman
- •Contraindication to MRI examination
- •Contraindication to including gadolinium salts injection
结局指标
主要结局
Temperature standard deviation
时间窗: Duration of MRI specific sequence (15 min)
To test the ability of this method to improve thermometry accuracy, temperature standard deviations will be studied. Indeed, temperature standard deviations reflect thermometry inaccuracy in absence of temperature variations. Temperature standard deviation in each pixel will be measured over a temporal window. Two regions of interest (ROI) determined by the operator will be considered: the first one in the tumor, the second one for the whole organ.
次要结局
- Characterization of tumor motion in 3D during respiratory cycles(Duration of MRI specific sequence (15 min))
- Improve of MRgHIFU shooting ballistics:(Duration of MRI specific sequence (15 min))
- HIFU platform improvements(Duration of MRI specific sequence (15 min))
