MRI Pseudo-CT Sequences for Obstetrical Pelvimetry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Prove the non-inferiority of MRI compared to CT for pelvimetry.
研究概览
简要总结
It is possible to perform a pelvimetry by MRI as a substitute to pelvimetry by CT, hence sparing the patient from a dose of irradiation.
详细描述
The Principal investigator want to evaluate new MRI sequences offering both an optimal contrast between mineral bone and soft tissues, and a shorter acquisition time. Indeed, the recent developments of specific MRI sequences to preferentially image the mineral bone (namely the ZTE and lavaflex 3D T1-weighted SPGR sequences) allow performing pelvimetry measurements on MR images offering an optimal "pseudo CT" contrast, with an MR acquisition time that is less than 10 minutes. Preliminary tests of these sequences have been carried out in our center in order to be able to implement these sequences on our clinical and research MRI machines. The study team wish to undertake a study to validate the use of this rapid and non-irradiating MRI approach, with the aim to replace a CT pelvimetry by a MRI pelvimetry demonstrated as being as reliable.
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 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant woman 33 to 41 week
- •Woman who gave birth by cesarean section, for whom the obstetrician requests a pelvimetry CT for the next pregnancy
- •Pelvimetry planned by the obstetrical team outside of "emergency" pathway
- •Adhere to the study protocol after reading the patient information document have signed the informed consent form to participate in the study
排除标准
- •Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
- •Severe claustrophobia
- •uncomfortable back position
结局指标
主要结局
Prove the non-inferiority of MRI compared to CT for pelvimetry.
时间窗: 30 minutes (duration of the exam+ measurement)
Measurement of pelvic bone diameters in pregnant women
次要结局
- Evaluate patient convenience for both examinations (CT and MRI)(immediately after both examinations)