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临床试验/NCT01197820
NCT01197820终止不适用

Hepatic and Renal Thermography Using Magnetic Resonance Imaging

University Hospital, Bordeaux4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年9月1日最近更新:
适应症

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

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))

研究者

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

研究点 (4)

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