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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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-
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Brindisi, Italien, 72100
- Perrino Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
From 314 women who underwent CEM between January 2022 and December 2023 at P.O. "A. Perrino", Brindisi, 213 met the eligibility criteria.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Inter-reader agreement for breast density and BPE grading, without and with AI support
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Prediction error (mean squared error) of linear regression and DNN versus a simple linear baseline, for BD and BPE
Tidsramme: 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
Tidsramme: 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
Tidsramme: Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Retrospective reading sessions on examinations performed between January 2022 and December 2023
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Gianluca Gatta, medicine and surgery, University of Campania Luigi Vanvitelli
- Ledende efterforsker: Graziella Di Grezia, medicine and surgery, Link Campus University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- T_3_2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Data are available upon request from the corresponding author
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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