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临床试验/NCT02516995
NCT02516995已完成不适用

Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer

Gustave Roussy, Cancer Campus, Grand Paris2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Quality of imaging [good/good enough/not good enough]

研究概览

简要总结

Merge the data of ultrasound with that of the anatomical and functional MRI is necessary since the high dose rate Curietherapy is carried out under ultrasound guidance. The investigators will recruit prostate cancer patients to evaluate the quality of the data, their sensitivity to exam conditions (patient position, volume of endorectal probe, gold grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from different sources with the purpose of estimating the opportunities of integration treatment plan for Curietherapy broadband.

The nuclear magnetic resonance imaging provides precise anatomical study, but also provides access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI), for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context, involving close collaboration between clinicians, medical physicists, and physicists of the teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital Kremlin-Bicetre).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients with prostate cancer biopsy-proven, intermediate or high risk (according to D'Amico Classification), for which radiotherapy is indicated.
  • Accepting the imaging tests.
  • Age <70 years.
  • Informed consent signed.

排除标准

  • Mental pathology that can interfere with the proper conduct of the study;
  • Claustrophobia;
  • Severe heart or respiratory disorder that can make it difficult to achieve relatively long imaging tests
  • Contraindications to magnetic resonance imaging (MRI)
  • pacemaker, other electronic appliance (depending on model);
  • heart valve, intra-cranial clip aneurysm, cerebral ventricular bypass valve (depending on model);
  • intraocular metallic foreign bodies (chips), and other locations, according to the site to discuss.
  • metal tracheostomy cannula;
  • endovascular stent or vascular embolization coils placed within six weeks in advance;
  • the impediments to a long examination with spectroscopy sequence of ten to twenty minutes: major tremors, inability to lie more than 30 minutes;
  • local sources of magnetic distortion which is sensitive spectroscopic imaging: hip replacement, prostate biopsy older than six weeks.

结局指标

主要结局

Quality of imaging [good/good enough/not good enough]

时间窗: Assessed six weeks after inclusion

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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