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临床试验/NCT03320343
NCT03320343已完成不适用

Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月22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
20
试验地点
2
主要终点
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus

研究概览

简要总结

The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient it at least 18 years old
  • The patient has been admitted for an MRI examination of the pelvic region, for any reason

排除标准

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breast feeding
  • There is a contra-indication for MRI (pacemaker, claustrophobic patient)
  • The patient has had previous pelvic surgery

研究组 & 干预措施

Patients recruited for pelvic imaging examination

干预措施: MRI (Other)

结局指标

主要结局

Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus

时间窗: Day 0

Lin's concordance correlation coefficient and Bland-Altman Plot

Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus

时间窗: Day 0

Lin's concordance correlation coefficient and Bland-Altman Plot

Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves

时间窗: Day 0

Lin's concordance correlation coefficient and Bland-Altman Plot

次要结局

  • Acquisition time(Day 0)
  • Intra-operator agreement(Month 6)
  • Time necessary for sequence reconstruction(Day 0)
  • Inter-operator agreement(Day 0)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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