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临床试验/NCT05056818
NCT05056818招募中不适用

Comparison of Synthetic Mammography Versus Full-Field Digital Mammography in Image Interpretation and Performance Metrics

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2020年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
750
试验地点
1
主要终点
To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM

研究概览

简要总结

This study compares synthetic mammography to full-field digital mammography in image interpretation and performance metrics. Digital breast tomosynthesis (DBT) has previously been found to be superior in performance to standard digital mammography in both screening and diagnostic settings for the early detection and improved diagnosis of breast cancers. DBT in combination with full-field digital mammography (FFDM) reduces recall rates and increases cancer detection rates relative to FFDM alone. Synthetic mammography is a 2-dimensional reconstructed image, using the dataset derived from the DBT acquisition, without requiring additional radiation dose. Collecting information from patients' medical records may help doctors analyze the characteristics, utility, and impact of synthetic mammography to compared to FFDM.

详细描述

PRIMARY OBJECTIVE:

I. To analyze the characteristics, utility, and impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM).

OUTLINE:

Patients' medical records and past imaging examinations are reviewed.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • •Age 18 or older
  • •Consecutive cases in breast imaging center

排除标准

  • •Cases demonstrate administrative or technical errors (e.g. missing views, labeling inconsistent with report, etc.)

研究组 & 干预措施

Observational (medical records)

Patients' medical records and past imaging examinations are reviewed.

干预措施: Electronic Health Record Review (Other)

结局指标

主要结局

To analyze the impact of synthetic mammography (SM), as compared with full-field digital mammography (FFDM

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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