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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Brindisi, Italië, 72100
- Perrino Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
From 314 women who underwent CEM between January 2022 and December 2023 at P.O. "A. Perrino", Brindisi, 213 met the eligibility criteria.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Inter-reader agreement for breast density and BPE grading, without and with AI support
Tijdsspanne: Retrospective reading sessions on examinations performed between January 2022 and December 2023
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Prediction error (mean squared error) of linear regression and DNN versus a simple linear baseline, for BD and BPE
Tijdsspanne: 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
Tijdsspanne: 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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External validation on 500 VinDr-Mammo BI-RADS C/D cases: MSE, R² and AUC for breast density
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Gianluca Gatta, medicine and surgery, University of Campania Luigi Vanvitelli
- Hoofdonderzoeker: Graziella Di Grezia, medicine and surgery, Link Campus University
Publicaties en nuttige links
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- T_3_2025
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
Data are available upon request from the corresponding author
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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