NCT06846814Enrolling By Invitation不适用
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
Graziella di Grezia1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Detection Rate of Additional Lesions on CEM
研究概览
简要总结
This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.
详细描述
The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Detection Rate of Additional Lesions on CEM
时间窗: Within 12 months of imaging assessment.
This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy.
次要结局
- Concordance Between Imaging Findings and Histopathology(Up to 3 months post-biopsy.)
- Concordance Between Imaging Findings and Follow-Up Imaging(6-12 months after the initial CEM examination)
研究者
Graziella di Grezia
Principal Investigator
Link Campus University
研究点 (1)
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