Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound ((Magnetic Resonance Imaging) Obtained in Vivo by the Koelis™ System
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accuracy of the overall registration obtained by the Koelis™ system
研究概览
简要总结
The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.
Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.
The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient requiring placement of intraprostatic fiducials
- •No contra-indication for fiducials placement
- •No contra -indication to MRI
- •No contra -indication for intravenous injection of gadolinium chelates
- •Patient affiliated to the social security system
- •Patients who received oral and written information
排除标准
- •Patient deprived of liberty as a result of a judicial or administrative decision.
- •Patient under guardianship or curatorship.
- •Any event preventing or prematurely interrupting the collection of assessment criteria would result in the premature exit of the subject.
结局指标
主要结局
Accuracy of the overall registration obtained by the Koelis™ system
时间窗: 1 month
The fusion will be performed retrospectively without interfering with patient management. This fusion is an off-line analysis that will be performed within one month of the images acquisition. Each of the four operators will perform a US/MR fusion for all patients and will be blinded to the fusions performed by the others. The results will be presented when all operators have finished the fusions in all patients. The overall registration error (TRE3D, defined as the Euclidean distance between the US marker and the MR marker after fusion) will be calculated based on the 3D coordinates of the fiducials on MR and ultrasound images.
次要结局
- Influence on TRE3D of the experience of the fusion operators(1 month)
- Influence on TRE3D of the position of the fiducials (apex, midgland and base)(1 month)