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临床试验/NCT04822272
NCT04822272已完成不适用

MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年7月8日最近更新:
适应症
干预措施

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

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

Experimental

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))

研究者

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

研究点 (1)

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