European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: EURAD-MR Classification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,340
- 试验地点
- 1
- 主要终点
- Reproducibility of the ADNEX MR scoring system between centers
研究概览
简要总结
This research is targeting patients with sonographically indeterminate adnexal mass that are being referred for clinical MR imaging. Investigators from the UW will be contributing coded MR images and associated health information (US results, laboratory/pathology results) to the EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the research.
详细描述
An adnexal mass is the most common indication for gynaecological surgery. Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patients management. Recently, the coordinating center developed the first MR scoring system named ANDEXMR SCORING system in a retrospective study which is accurate and reproducible. The objectives of this trial are to perform an external prospective validation of this scoring system to evaluate its potential impact on therapeutic strategy and to test its reproducibility.
This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be included from each participating center. One senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The reader will then classify the mass using ADNEXMR SCORING system.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older
- •With indeterminate ultrasonographic adnexal mass
排除标准
- •Patients under 18 years of age
结局指标
主要结局
Reproducibility of the ADNEX MR scoring system between centers
时间窗: 24 months
Evaluate if ADNEXMR SCORING system is relevant for reporting pelvic magnetic resonance imaging (MRI) examinations performed for characterization of sonographically indeterminate adnexal masses in an external prospective multicenter study
次要结局
- Differences in rate of surgery in women with adnexal lesions in those where the ADNEX MR score is used compared to when it is not used.(24 months)
- Reproducibility of the score(24 months)
- Comparison between a blinded and an unblinded radiologist regarding sonographic data(24 months)