Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 347
- 试验地点
- 2
- 主要终点
- Diagnostic performances comparison between CT and MRI
研究概览
简要总结
Objective :
To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.
详细描述
Methods :
Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the emergency Physician or gynaecologist after a non contributive ultrasonography will be included.
After obtaining informed consent, all patients will undergo standard CT followed by an additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.
The gold standard or reference diagnosis will be established in consensus by an expert panel at 3 months follow up using a standardized diagnosis form.
A retrospective reading will be performed independently for CT and MRI by radiologists blinded to the reference diagnosis, using the same standardized diagnosis form.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-40 years old
- •Women referred to CT following a non contributive ultrasonography
- •Women with acute non traumatic abdominopelvic pain (less than 5 day-duration)
- •Women with informed consent
- •Women with affiliation to health insurance
排除标准
- •Women who underwent abdominopelvic surgery in the previous month
- •Suspicion of vital emergency such as shock preventing any delayed management caused by MRI examination
- •Contra-indication to MRI, including pace maker, ferro-magnetic material, foreign bodies with risk of mobilization during MRI examination
- •Women yet included in the study or included in another study
- •Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding
- •Women unable to undergo informed consent (vulnerable or protected by law)
结局指标
主要结局
Diagnostic performances comparison between CT and MRI
时间窗: 3 months
Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
次要结局
- Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive(3 months)
- Diagnostic performances of unenhanced MRI sequences versus complete MRI examination(3 months)
- Inter-reader agreement for MRI and CT diagnoses(3 months)