跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT01910103
NCT01910103已完成不适用

Comparison of Diagnostic Performance of Digital Breast Tomosynthesis and Ultrasound in Women With Dense Breasts

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 825 人开始时间: 2013年6月最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
825
试验地点
1
主要终点
Diagnostic performance (AUC: area of under ROC curve) of DBT and US
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Diagnostic performance of digital breast tomosynthesis (DBT) would be not inferior to the that of breast ultrasound in women with dense breast.

详细描述

  1. Patients with dense breast will be examined for the detection of breast cancer by imaging studies.
  2. The imaging including digital breast tomosynthesis (DBT), physician-performed bilateral whole breast ultrasonography will be performed according to a standard protocol.Interpretation will be conducted independently and classified according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists.
  3. Definitive information about the presence of malignancy will be obtained by biopsy directed by the imaging method best depicting the lesion with 14-g or 11-g needle devices or needle localized excision. The absence of breast cancer was determined by means of biopsy, the absence of positive findings on repeat imaging and clinical examination, or both at follow-up.
  4. The diagnostic yield of digital breast tomosynthesis (DBT) compared to ultrasonography will be assessed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Women aged at 20 years
  • •Women who had heterogeneously dense or extremely dense parenchyma, either by prior mammography report or by review of prior mammograms
  • •Signed study-specific informed consent prior to registration

排除标准

  • •Had breast surgery
  • •Had breast core biopsy performed within the prior 6 months on the study

结局指标

主要结局

Diagnostic performance (AUC: area of under ROC curve) of DBT and US

时间窗: one year

The primary endpoint will be an analysis of the diagnostic performance of DBT to that of US for detecting breast cancer in the screening and diagnostic setting. The hypothesis is that DBT is not inferior to US for detecting breast cancer.

次要结局

  • Diagnostic sensitivity, sensitivity, negative predictive value, and positive predictive value of DBT and US for detecting breast cancer.(One year)

研究者

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

Jung Min Chang

Clinical Assistant Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验

Unknown
4 期
Tomosynthesis Versus Digital Mammography in a Population-based Screening ProgramBreast Cancer
NCT02590315Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte92,000
已完成
不适用
Assessment of Digital Breast Tomosynthesis (DBT) in the Screening EnvironmentBreast Abnormalities
NCT01106911University of Pittsburgh1,080
已完成
不适用
Digital Breast Tomosynthesis in Younger Symptomatic WomenBreast Cancer
NCT01241981NHS Tayside446
撤回
不适用
Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital MammographyBreast Cancer
NCT01593384Case Comprehensive Cancer Center
招募中
不适用
Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis SystemsArchitectural DistortionsBreast Tomosynthesis
NCT06373354M.D. Anderson Cancer Center100