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临床试验/NCT06311695
NCT06311695Unknown2 期

The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer

European Institute of Oncology2 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2020年11月16日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
263
试验地点
2
主要终点
Evaluation of negative predictive value (NPV) of the CEM

研究概览

简要总结

The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).

详细描述

Breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy.

Improvement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages.

The main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings.

The main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. The reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. The sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts.

For this purpose, a diagnostic technique called contrast-enhanced mammography (CEM) has been developed in recent years: CEM is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (FDA).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with breast lesions, who underwent bilateral CEM
  • Histological assessment

排除标准

  • The subject is known to have risks of adverse effects with iodine contrast agents
  • The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination

结局指标

主要结局

Evaluation of negative predictive value (NPV) of the CEM

时间窗: 1 month

Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB. Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM

次要结局

  • Evaluation of specificity of CEM(1 month)
  • Positive Predictive Value (PPV) of CEM(1 month)
  • Evaluation of sensitivity of CEM(1 month)

研究者

发起方
European Institute of Oncology
申办方类型
Other
责任方
Sponsor

研究点 (2)

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