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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Brindisi, Italia, 72100
- Perrino Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
From 314 women who underwent CEM between January 2022 and December 2023 at P.O. "A. Perrino", Brindisi, 213 met the eligibility criteria.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: RETROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Inter-reader agreement for breast density and BPE grading, without and with AI support
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Prediction error (mean squared error) of linear regression and DNN versus a simple linear baseline, for BD and BPE
Lasso di tempo: Retrospective reading sessions on examinations performed between January 2022 and December 2023
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Retrospective reading sessions on examinations performed between January 2022 and December 2023
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Classification performance (AUC, precision, recall, F1-score) of the models
Lasso di tempo: Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
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External validation on 500 VinDr-Mammo BI-RADS C/D cases: MSE, R² and AUC for breast density
Lasso di tempo: Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Gianluca Gatta, medicine and surgery, University of Campania Luigi Vanvitelli
- Investigatore principale: Graziella Di Grezia, medicine and surgery, Link Campus University
Pubblicazioni e link utili
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- T_3_2025
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Data are available upon request from the corresponding author
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