Reproducibility of Breast Density and Background Parenchymal Enhancement Grading on Contrast-Enhanced Mammography With AI Support: A Retrospective Single-Centre Study (BD/BPE_CEM)
Beyond Cancer Detection: An AI Framework for Multidimensional Risk Profiling on Contrast-Enhanced Mammography Acronym: AI-CEM-RISK
Retrospective single-centre observational study in women who underwent contrast-enhanced mammography (CEM). It assesses the reproducibility of breast density (BD) and background parenchymal enhancement (BPE) grading by five radiologists with and without AI support, develops linear regression and deep neural network (DNN) models to predict BD and BPE, tests BD prediction on an external public dataset, and explores a multi-output DNN as a proof of concept for proxy estimates of bone mineral density and systolic blood pressure. This is a secondary analysis of the cohort also described in NCT06838117 and NCT06838130.
研究概览
地位
详细说明
Women referred for diagnostic CEM at the Interventional Breast Unit of P.O. "A. Perrino", Brindisi, were analyzed. Five breast radiologists independently graded BD (BI-RADS A-D) and BPE (minimal to marked) and consensus served as ground truth. Linear regression and a DNN were compared with a simple linear baseline. Inter-reader agreement was measured with Fleiss' kappa. The external validation used 500 BI-RADS C/D cases from VinDr-Mammo and was restricted to density endpoints. The multi-output analysis was hypothesis-generating; bone density and blood pressure outputs are proxy estimates, not measured values.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Brindisi、意大利、72100
- Perrino Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
From 314 women who underwent CEM between January 2022 and December 2023 at P.O. "A. Perrino", Brindisi, 213 met the eligibility criteria.
描述
Inclusion Criteria: women aged 28-80 years referred for CEM for diagnostic work-up; histopathology available for BI-RADS 4/5 findings; inclusion not restricted to malignant cases.
Exclusion Criteria: previous history of malignancy; breast biopsy within three weeks before imaging; contraindications to iodinated contrast medium; incomplete imaging records.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：RETROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Women undergoing CEM for diagnostic work-up
Women aged 28-80 years referred for CEM at the Interventional Breast Unit, P.O. "A. Perrino", Brindisi. Histopathology was available for BI-RADS 4/5 findings. |
Diagnostic Test: contrast-enhanced mammography (Senographe Pristina, GE Healthcare), performed as routine care. Other: AI-assisted grading of breast density and BPE (linear regression and deep neural network). |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Inter-reader agreement for breast density and BPE grading, without and with AI support
大体时间：Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Fleiss' kappa among five radiologists for BD and for BPE, baseline versus AI-assisted reading. |
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Prediction error (mean squared error) of linear regression and DNN versus a simple linear baseline, for BD and BPE
大体时间：Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
|
Classification performance (AUC, precision, recall, F1-score) of the models
大体时间：Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
|
External validation on 500 VinDr-Mammo BI-RADS C/D cases: MSE, R² and AUC for breast density
大体时间：Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
合作者和调查者
调查人员
- 学习椅：Gianluca Gatta, medicine and surgery、University of Campania Luigi Vanvitelli
- 首席研究员：Graziella Di Grezia, medicine and surgery、Link Campus University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- T_3_2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Data are available upon request from the corresponding author
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.