MagneThermoPro : Magnetic Resonance Thermography of Human Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- signal noise ratio
研究概览
简要总结
The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance
详细描述
Prostate MRI has become the benchmark examination to search for tumor targets, thanks to a multi-parameter protocol, including T2 sequences, diffusions, and T1 with gadolinium injection. A PIRADS prognostic score is performed on the different sequences and if the lesions are at high risk of malignancy (PIRADS 4 and 5), a targeted biopsy is performed. Minimally invasive ablations called focal treatments are developing more and more: HIFU, cryotherapy, laser, etc. Ultrasound remains the most widespread examination due to its availability, but with less sensitivity than MRI. Ablations are performed under ultrasound with fusion of MRI images In order to assess the ablation area under MRI, the measurement of temperature variations appears necessary to verify the effectiveness of ablation and the lesion volume. Temperature maps are feasible in cardiac MRI during radiofrequency. The thermal mapping MRI sequence is performed in cardiac MRI at the IHU in Bordeaux.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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 old
- •Patient with indication of injected multi-parameter MRI for the diagnosis of prostate cancer.
- •Signed informed consent.
- •Person affiliated or beneficiary of health insurance
排除标准
- •MRI contraindications (Pace Maker, metallic foreign body, metallic heart valve).
- •Contraindication to gadolinium salt,
- •Patient under legal protection
研究组 & 干预措施
Thermometry MRI
MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
干预措施: MRI thermometry (Device)
结局指标
主要结局
signal noise ratio
时间窗: End of MRI exam (hour 1)
the evaluation of the signal on the thermometry sequence
次要结局
- temperature variance(End of MRI exam (hour 1))
- spatial distortion measurement(End of MRI exam (hour 1))
