Maciej Bobowicz

Karim Lekadir, Aasa Feragen, Abdul Joseph Fofanah et al. · eth-zurich

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.

Lidia Garrucho, Kaisar Kushibar, Richard Osuala et al.

Computer-aided detection systems based on deep learning have shown good performance in breast cancer detection. However, high-density breasts show poorer detection performance since dense tissues can mask or even simulate masses. Therefore, the sensitivity of mammography for breast cancer detection can be reduced by more than 20% in dense breasts. Additionally, extremely dense cases reported an increased risk of cancer compared to low-density breasts. This study aims to improve the mass detection performance in highdensity breasts using synthetic high-density full-field digital mammograms (FFDM) as data augmentation during breast mass detection model training. To this end, a total of five cycle-consistent GAN (CycleGAN) models using three FFDM datasets were trained for low-to-high-density image translation in highresolution mammograms. The training images were split by breast density BIRADS categories, being BI-RADS A almost entirely fatty and BI-RADS D extremely dense breasts. Our results showed that the proposed data augmentation technique improved the sensitivity and precision of mass detection in models trained with small datasets and improved the domain generalization of the models trained with large databases. In addition, the clinical realism of the synthetic images was evaluated in a reader study involving two expert radiologists and one surgical oncologist.

Lidia Garrucho, Smriti Joshi, Kaisar Kushibar et al.

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 often developed using single-center data and evaluated using aggregate performance metrics, limiting their generalizability and obscuring potential performance disparities across demographic subgroups. The MAMA-MIA Challenge was designed to address these limitations by introducing a large-scale benchmark that jointly evaluates 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 external testing 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.

Shruti Atul Mali, Zohaib Salahuddin, Yumeng Zhang et al.

Colorectal liver metastases (CRLM) are a major cause of cancer-related mortality, and reliable detection on CT remains challenging in multi-centre settings. We developed a foundation model-based AI pipeline for patient-level classification and lesion-level detection of CRLM on contrast-enhanced CT, integrating uncertainty quantification and explainability. CT data from the EuCanImage consortium (n=2437) and an external TCIA cohort (n=197) were used. Among several pretrained models, UMedPT achieved the best performance and was fine-tuned with an MLP head for classification and an FCOS-based head for lesion detection. The classification model achieved an AUC of 0.90 and a sensitivity of 0.82 on the combined test set, with a sensitivity of 0.85 on the external cohort. Excluding the most uncertain 20 percent of cases improved AUC to 0.91 and balanced accuracy to 0.86. Decision curve analysis showed clinical benefit for threshold probabilities between 0.30 and 0.40. The detection model identified 69.1 percent of lesions overall, increasing from 30 percent to 98 percent across lesion size quartiles. Grad-CAM highlighted lesion-corresponding regions in high-confidence cases. These results demonstrate that foundation model-based pipelines can support robust and interpretable CRLM detection and classification across heterogeneous CT data.

Grzegorz Skorupko, Fotios Avgoustidis, Carlos Martín-Isla et al.

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 .

Lidia Garrucho, Kaisar Kushibar, Claire-Anne Reidel et al.

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.