Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 6
- 主要终点
- Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence
研究概览
简要总结
Inclusion visit (D0):
- verification of inclusion and non-inclusion criteria
- information and collection of consent
- standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
- 3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).
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
- 否
入选标准
- •Patient over 18 years old
- •To benefit from a medullary exploration planned by MRI 1.5T as part of a first evaluation or a re-evaluation of inflammatory involvement of the nevrax
- •Express consent to participate in the study
- •Affiliate or beneficiary of a social security scheme
排除标准
- •Patient benefiting from a legal protection measure
- •Pregnant, parturient or breastfeeding woman
- •Absolute or relative contraindication to MRI
结局指标
主要结局
Measure the intra-observer agreement on the number of lesions detected with the 3D PSIR sequence
时间窗: 1 DAY
Estimate the number of active lesions taking the contrast after injection of gadolinium, with the 3D PSIR sequence which is not detected in the set of standard sequences (T1, T2 and STIR)
时间窗: 1 day
Compare the diagnostic confidence expressed by the radiologist for the detection of spinal cord injuries with the 3D PSIR sequence compared to the set of standard sequences (T1, T2 and STIR)
时间窗: 1 DAY
Measure the signal-to-noise ratio of each of the sequences used (T1, T2, STIR and PSIR)
时间窗: 1 DAY
Measure the inter-observer agreement on the number of lesions detected with the 3D PSIR sequence
时间窗: 1 DAY
Describe the quality of the images in terms of artifacts for each of the sequences used (T1, T2, STIR and PSIR)
时间窗: 1 DAY
Estimate the number of spinal cord injuries detected with the set of standard sequences (T1, T2 and STIR) that are not detected with the 3D PSIR sequence
时间窗: 1 DAY
次要结局
未报告次要终点