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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brindisi, Italia, 72100
- Perrino Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
From 314 women who underwent CEM between January 2022 and December 2023 at P.O. "A. Perrino", Brindisi, 213 met the eligibility criteria.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inter-reader agreement for breast density and BPE grading, without and with AI support
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Prediction error (mean squared error) of linear regression and DNN versus a simple linear baseline, for BD and BPE
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Gianluca Gatta, medicine and surgery, University of Campania Luigi Vanvitelli
- Investigador principal: Graziella Di Grezia, medicine and surgery, Link Campus University
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- T_3_2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Data are available upon request from the corresponding author
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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