跳至主要内容
临床试验/NCT06687902
NCT06687902进行中(未招募)不适用

Added Value of Digital Breast Tomosynthesis in Characterization of Breast Lesions

Sohag University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Compare DBT with traditional mammography in terms of diagnostic accuracy, sensitivity, and specificity for detecting and differentiating benign and malignant breast lesions

研究概览

简要总结

The aim of the study is to evaluate the added value of digital breast tomosynthesis (DBT) in the characterization of breast lesions.

详细描述

All patients enrolled in the study will undergo both 2D digital mammography and digital breast tomosynthesis (DBT), using standardized protocols. The DM plus DBT acquisition commonly referred to as "combo" mode , that has shown an improvement in specificity and sensitivity , but at approximately doubling of the radiation dose . This approach will provide a consistent framework for evaluating the diagnostic capabilities of both techniques in characterizing breast masses.

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

性别
Female
接受健康志愿者

入选标准

  • Patients with mammographic breast lesions of BIRADS III, IV.
  • Dense breast in patients with complaints (BIRADS 0) which needed further assessment.

排除标准

  • Pregnant females to avoid the hazards of ionizing radiation to the fetus.
  • Patients with known metastatic breast cancer.

结局指标

主要结局

Compare DBT with traditional mammography in terms of diagnostic accuracy, sensitivity, and specificity for detecting and differentiating benign and malignant breast lesions

时间窗: 1 hour

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shorouk Salaheldien Ali

M.B.B.Ch

Sohag University

研究点 (2)

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