Diagnostic Accuracy of Multiparametric Dynamic Contrast Enhanced Magnetic Resonance Imaging in Improving Detection of Ultrasound Non-mass Breast Lesions According to ACR BI-RADS v2025
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound
研究概览
简要总结
this study aims To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.
The study will investigate whether DCE-MRI improves lesions detected by characterization and diagnostic accuracy when interpreted according to the ACR BIRADS v 2025 and so may help optimize breast imaging evaluation and support clinical decision making
详细描述
- Background: Non-mass breast lesions detected by ultrasound may present diagnostic challenges because of their variable imaging appearances and overlap between benign and malignant findings.
- Objective: To evaluate the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions according to ACR BIRADS v 2025.
- Methods: This observational study will include patients with non-mass breast lesions identified on breast ultrasound or mammography. Participants will undergo breast MRI examination including dynamic contrast-enhanced sequences. Imaging findings will be assessed according to ACR BI-RADS 2025 criteria .
- Outcome Measures: The primary outcome will be the diagnostic performance of DCE-MRI, including sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy in differentiating benign from malignant lesions.
- Significance: The study aims to determine whether multiparametric DCE-MRI can improve characterization of ultrasound-detected non-mass breast lesions and support more accurate clinical decision-making.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Female patients of any age presenting with non-mass breast lesions detected on MRI or conventional imaging.
- •Patients who have both MRI and targeted Ultrasound examinations.
排除标准
- •• Patients presenting with typical distinct "mass" lesions (3D space-occupying lesions) without any non-mass components.
- •Patients with absolute contraindications to MRI (e.g., cardiac pacemakers, severe claustrophobia, non-compatible metallic implants).
- •Patients with contraindications to intravenous Gadolinium contrast media (e.g., severe renal impairment/failure, pregnancy, known history of severe allergic reaction to gadolinium).
结局指标
主要结局
Diagnostic accuracy of Multiparametric DCE-MRI in characterization of non mass breast lesions detected on Ultrasound
时间窗: 8 months
evaluation the diagnostic performance of Ultrasound (US) in correlation with Dynamic Magnetic Resonance Imaging (MRI) for the assessment, characterization, and evaluation of non-mass breast lesions.
次要结局
未报告次要终点
研究者
Alaa Nor Abdelghafar
Assistant Lecturer of Diagnostic and Interventional Radiology, Faculty of Medicine , Sohag University
Sohag University