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临床试验/NCT04832191
NCT04832191Unknown不适用

1.3 Role of Contrast-enhanced Mammography and Dynamic Contrast-enhanced MRI in the Assessment of Solid Breast Lesions

Assiut University0 个研究点目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
comparison between accuracy of CESM and CE-MRI in diagnosing breast cancer.

研究概览

简要总结

Our study aimed to assess the accuracy of CE-SM in comparison to contrast-enhanced breast MRI in the evaluation of solid breast lesions.

详细描述

Breast cancer is the most common cancer in women, responsible for 23% of cancer in females worldwide (1).

Early detection and accurate diagnosis of breast cancer aims to reduce morbidity and mortality and have essential role in management and improved prognosis of breast cancer (2).

Mammography has been established as the imaging modality for screening and early detection of breast cancer; however, it is accused of having low sensitivity and specificity in women with dense breasts (3).

Contrast-enhanced MRI considered the gold standard method for diagnosis of breast cancer; but, it has many limitations as high cost, long examination time and limited availability (4,5).

Contrast-enhanced spectral mammogram (CESM) is considered now a relatively new imaging modality which can provide both anatomic and functional information of the breast lesion similar to MRI (6).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who have previously undergone mammography (MG) and ultrasound and have a solid (BIRADs III and more) breast lesion.

排除标准

  • Cystic breast lesions
  • BIRADs I and II breast lesions(benign)
  • Pregnancy
  • History of allergic reaction to iodinated contrast agent
  • Renal insufficiency
  • Other contraindications to MRI include pacemaker, claustrophobia or metal prosthesis.

结局指标

主要结局

comparison between accuracy of CESM and CE-MRI in diagnosing breast cancer.

时间窗: baseline

Measurement of sensitivity, specificity and predictive values of CESM and CE-MRI in diagnosing breast cancer.

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

Basma Fawzy Mohamed Gad El-Rab

Assistant professor

Assiut University

相似试验

CE-MRI&CESM in Solid Breast Lesions | 临床试验