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Oliver Díaz

Publications and source records attributed to Oliver Díaz.

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The MAMA-MIA Challenge: Advancing Generalizability and Fairness in Breast MRI Tumor Segmentation and Treatment Response Prediction

Breast cancer is the most frequently diagnosed malignancy among women worldwide and a leading cause of cancer-related mortality. Dynamic contrast-enhanced magnetic resonance imaging plays a central role in tumor characterization and treatment monitoring, particularly in patients receiving neoadjuvant chemotherapy. However, existing artificial intelligence models for breast magnetic resonance imaging are typically developed and evaluated using heterogeneous datasets, study populations, and assessment protocols, making direct comparison difficult and limiting understanding of model robustness across institutions and clinically relevant patient subgroups. The MAMA-MIA Challenge was designed to address these challenges by providing a standardized benchmark for the joint evaluation of primary tumor segmentation and prediction of pathologic complete response using pre-treatment magnetic resonance imaging only. The training cohort comprised 1,506 patients from multiple institutions in the United States, while evaluation was conducted on an external test set of 574 patients from three independent European centers to assess cross-continental and cross-institutional generalization. A unified scoring framework combined predictive performance with subgroup consistency across age, menopausal status, and breast density. Twenty-six international teams participated in the final evaluation phase. Results demonstrate substantial performance variability under a common external evaluation framework and reveal trade-offs between overall accuracy and subgroup fairness. The challenge provides standardized datasets, evaluation protocols, and public resources to promote the development of robust and equitable artificial intelligence systems for breast cancer imaging.

cs.CV

Regulatory Approval Is Not Enough: Gaps in Trustworthy AI Reporting in FDA-Cleared Medical Devices

Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks. As these systems become more integrated into clinical decision-making, there is growing expectation that they demonstrate key dimensions of trustworthy AI to support clinician, patient, and public trust. Whether publicly available regulatory documentation provides sufficient evidence to independently assess the trustworthiness of cleared AI systems remains unclear. Methods: We analysed FDA AI/ML-enabled medical device summary reports published between 2021 and 2025. Reports underwent automated keyword screening followed by multi-stage manual consensus review to identify documented evidence for the six FUTURE-AI principles: Fairness, Universality, Traceability, Usability, Robustness, and Explainability. Descriptive, temporal, and clinical-domain analyses were performed. Multivariable logistic regression assessed whether year of clearance or clinical domain predicted higher reporting transparency, defined as evidence reported for three or more principles. Results: Of 1,105 FDA summary reports screened, 519 were included. Trustworthy AI reporting was limited and uneven. Nearly one quarter (24.7%) provided no evidence for any principle, and none documented evidence across all six. Robustness was most frequently reported (57.6%), while Traceability (8.3%) and Explainability (3.5%) were the most pronounced gaps. Neither year of clearance (OR 1.02, 95% CI 0.88-1.19) nor clinical domain (OR 0.73, 95% CI 0.46-1.15) predicted higher reporting transparency. Interpretation: Substantial, persistent trustworthy AI reporting gaps exist in FDA documentation. Regulatory approval alone should not be considered a proxy for trustworthiness. Standardised, audit-ready reporting across the AI lifecycle is needed to support independent assessment and responsible adoption of healthcare AI.

cs.CY

Federated nnU-Net for Privacy-Preserving Medical Image Segmentation

The nnU-Net framework has played a crucial role in medical image segmentation and has become the gold standard in multitudes of applications targeting different diseases, organs, and modalities. However, so far it has been used primarily in a centralized approach where the collected data is stored in the same location where nnU-Net is trained. This centralized approach has various limitations, such as potential leakage of sensitive patient information and violation of patient privacy. Federated learning has emerged as a key approach for training segmentation models in a decentralized manner, enabling collaborative development while prioritising patient privacy. In this paper, we propose FednnU-Net, a plug-and-play, federated learning extension of the nnU-Net framework. To this end, we contribute two federated methodologies to unlock decentralized training of nnU-Net, namely, Federated Fingerprint Extraction (FFE) and Asymmetric Federated Averaging (AsymFedAvg). We conduct a comprehensive set of experiments demonstrating high and consistent performance of our methods for breast, cardiac and fetal segmentation based on a multi-modal collection of 6 datasets representing samples from 18 different institutions. To democratize research as well as real-world deployments of decentralized training in clinical centres, we publicly share our framework at https://github.com/faildeny/FednnUNet .

cs.CV

Segmentation variability and radiomics stability for predicting Triple-Negative Breast Cancer subtype using Magnetic Resonance Imaging

Most papers caution against using predictive models for disease stratification based on unselected radiomic features, as these features are affected by contouring variability. Instead, they advocate for the use of the Intraclass Correlation Coefficient (ICC) as a measure of stability for feature selection. However, the direct effect of segmentation variability on the predictive models is rarely studied. This study investigates the impact of segmentation variability on feature stability and predictive performance in radiomics-based prediction of Triple-Negative Breast Cancer (TNBC) subtype using Magnetic Resonance Imaging. A total of 244 images from the Duke dataset were used, with segmentation variability introduced through modifications of manual segmentations. For each mask, explainable radiomic features were selected using the Shapley Additive exPlanations method and used to train logistic regression models. Feature stability across segmentations was assessed via ICC, Pearson's correlation, and reliability scores quantifying the relationship between feature stability and segmentation variability. Results indicate that segmentation accuracy does not significantly impact predictive performance. While incorporating peritumoral information may reduce feature reproducibility, it does not diminish feature predictive capability. Moreover, feature selection in predictive models is not inherently tied to feature stability with respect to segmentation, suggesting that an overreliance on ICC or reliability scores for feature selection might exclude valuable predictive features.

stat.AP

A large-scale multicenter breast cancer DCE-MRI benchmark dataset with expert segmentations

Artificial Intelligence (AI) research in breast cancer Magnetic Resonance Imaging (MRI) faces challenges due to limited expert-labeled segmentations. To address this, we present a multicenter dataset of 1506 pre-treatment T1-weighted dynamic contrast-enhanced MRI cases, including expert annotations of primary tumors and non-mass-enhanced regions. The dataset integrates imaging data from four collections in The Cancer Imaging Archive (TCIA), where only 163 cases with expert segmentations were initially available. To facilitate the annotation process, a deep learning model was trained to produce preliminary segmentations for the remaining cases. These were subsequently corrected and verified by 16 breast cancer experts (averaging 9 years of experience), creating a fully annotated dataset. Additionally, the dataset includes 49 harmonized clinical and demographic variables, as well as pre-trained weights for a baseline nnU-Net model trained on the annotated data. This resource addresses a critical gap in publicly available breast cancer datasets, enabling the development, validation, and benchmarking of advanced deep learning models, thus driving progress in breast cancer diagnostics, treatment response prediction, and personalized care.

cs.CV

FUTURE-AI: International consensus guideline for trustworthy and deployable artificial intelligence in healthcare

Despite major advances in artificial intelligence (AI) for medicine and healthcare, the deployment and adoption of AI technologies remain limited in real-world clinical practice. In recent years, concerns have been raised about the technical, clinical, ethical and legal risks associated with medical AI. To increase real world adoption, it is essential that medical AI tools are trusted and accepted by patients, clinicians, health organisations and authorities. This work describes the FUTURE-AI guideline as the first international consensus framework for guiding the development and deployment of trustworthy AI tools in healthcare. The FUTURE-AI consortium was founded in 2021 and currently comprises 118 inter-disciplinary experts from 51 countries representing all continents, including AI scientists, clinicians, ethicists, and social scientists. Over a two-year period, the consortium defined guiding principles and best practices for trustworthy AI through an iterative process comprising an in-depth literature review, a modified Delphi survey, and online consensus meetings. The FUTURE-AI framework was established based on 6 guiding principles for trustworthy AI in healthcare, i.e. Fairness, Universality, Traceability, Usability, Robustness and Explainability. Through consensus, a set of 28 best practices were defined, addressing technical, clinical, legal and socio-ethical dimensions. The recommendations cover the entire lifecycle of medical AI, from design, development and validation to regulation, deployment, and monitoring. FUTURE-AI is a risk-informed, assumption-free guideline which provides a structured approach for constructing medical AI tools that will be trusted, deployed and adopted in real-world practice. Researchers are encouraged to take the recommendations into account in proof-of-concept stages to facilitate future translation towards clinical practice of medical AI.

cs.CY

Mitigating annotation shift in cancer classification using single image generative models

Artificial Intelligence (AI) has emerged as a valuable tool for assisting radiologists in breast cancer detection and diagnosis. However, the success of AI applications in this domain is restricted by the quantity and quality of available data, posing challenges due to limited and costly data annotation procedures that often lead to annotation shifts. This study simulates, analyses and mitigates annotation shifts in cancer classification in the breast mammography domain. First, a high-accuracy cancer risk prediction model is developed, which effectively distinguishes benign from malignant lesions. Next, model performance is used to quantify the impact of annotation shift. We uncover a substantial impact of annotation shift on multiclass classification performance particularly for malignant lesions. We thus propose a training data augmentation approach based on single-image generative models for the affected class, requiring as few as four in-domain annotations to considerably mitigate annotation shift, while also addressing dataset imbalance. Lastly, we further increase performance by proposing and validating an ensemble architecture based on multiple models trained under different data augmentation regimes. Our study offers key insights into annotation shift in deep learning breast cancer classification and explores the potential of single-image generative models to overcome domain shift challenges.

cs.CV