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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Brindisi、イタリア、72100
- Perrino Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
From 314 women who underwent CEM between January 2022 and December 2023 at P.O. "A. Perrino", Brindisi, 213 met the eligibility criteria.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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). |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Inter-reader agreement for breast density and BPE grading, without and with AI support
時間枠：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
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Prediction error (mean squared error) of linear regression and DNN versus a simple linear baseline, for BD and BPE
時間枠：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
時間枠：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
時間枠：Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Gianluca Gatta, medicine and surgery、University of Campania Luigi Vanvitelli
- 主任研究者：Graziella Di Grezia, medicine and surgery、Link Campus University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- T_3_2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data are available upon request from the corresponding author
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。