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Protocol of the observational study STRATUM-OS: First step in the development and validation of the STRATUM tool based on multimodal data processing to assist surgery in patients affected by intra-axial brain tumours

Fabelo, H., Ramallo-Farina, Y., Morera, J., Pineiro, J. F., Lagares, A., Jimenez-Roldan, L., Burstrom, G., Garcia-Bello, M. A., Garcia-Perez, L., Falero, R., Gonzalez, M., Duque, S., Rodriguez-Jimenez, C., Hernandez, M., Delgado-Sanchez, J. J., Paredes, A. B., Hernandez, G., Ponce, P., Leon, R., Gonzalez-Martin, J. M., Rodriguez-Esparragon, F., Callico, G. M., Wagner, A. M., Clavo, B., STRATUM,

medrxiv logopreprintJun 13 2025
IntroductionIntegrated digital diagnostics can support complex surgeries in many anatomic sites, and brain tumour surgery represents one of the most complex cases. Neurosurgeons face several challenges during brain tumour surgeries, such as differentiating critical tissue from brain tumour margins. To overcome these challenges, the STRATUM project will develop a 3D decision support tool for brain surgery guidance and diagnostics based on multimodal data processing, including hyperspectral imaging, integrated as a point-of-care computing tool in neurosurgical workflows. This paper reports the protocol for the development and technical validation of the STRATUM tool. Methods and analysisThis international multicentre, prospective, open, observational cohort study, STRATUM-OS (study: 28 months, pre-recruitment: 2 months, recruitment: 20 months, follow-up: 6 months), with no control group, will collect data from 320 patients undergoing standard neurosurgical procedures to: (1) develop and technically validate the STRATUM tool, and (2) collect the outcome measures for comparing the standard procedure versus the standard procedure plus the use of the STRATUM tool during surgery in a subsequent historically controlled non-randomized clinical trial. Ethics and disseminationThe protocol was approved by the participant Ethics Committees. Results will be disseminated in scientific conferences and peer-reviewed journals. Trial registration number[Pending Number] ARTICLE SUMMARYO_ST_ABSStrengths and limitations of this studyC_ST_ABSO_LISTRATUM-OS will be the first multicentre prospective observational study to develop and technically validate a 3D decision support tool for brain surgery guidance and diagnostics in real-time based on artificial intelligence and multimodal data processing, including the emerging hyperspectral imaging modality. C_LIO_LIThis study encompasses a prospective collection of multimodal pre, intra and postoperative medical data, including innovative imaging modalities, from patients with intra-axial brain tumours. C_LIO_LIThis large observational study will act as historical control in a subsequent clinical trial to evaluate a fully-working prototype. C_LIO_LIAlthough the estimated sample size is deemed adequate for the purpose of the study, the complexity of the clinical context and the type of surgery could potentially lead to under-recruitment and under-representation of less prevalent tumour types. C_LI

Clinically reported covert cerebrovascular disease and risk of neurological disease: a whole-population cohort of 395,273 people using natural language processing

Iveson, M. H., Mukherjee, M., Davidson, E. M., Zhang, H., Sherlock, L., Ball, E. L., Mair, G., Hosking, A., Whalley, H., Poon, M. T. C., Wardlaw, J. M., Kent, D., Tobin, R., Grover, C., Alex, B., Whiteley, W. N.

medrxiv logopreprintJun 13 2025
ImportanceUnderstanding the relevance of covert cerebrovascular disease (CCD) for later health will allow clinicians to more effectively monitor and target interventions. ObjectiveTo examine the association between clinically reported CCD, measured using natural language processing (NLP), and subsequent disease risk. Design, Setting and ParticipantsWe conducted a retrospective e-cohort study using linked health record data. From all people with clinical brain imaging in Scotland from 2010 to 2018, we selected people with no prior hospitalisation for neurological disease. The data were analysed from March 2024 to June 2025. ExposureFour phenotypes were identified with NLP of imaging reports: white matter hypoattenuation or hyperintensities (WMH), lacunes, cortical infarcts and cerebral atrophy. Main outcomes and measuresHazard ratios (aHR) for stroke, dementia, and Parkinsons disease (conditions previously associated with CCD), epilepsy (a brain-based control condition) and colorectal cancer (a non-brain control condition), adjusted for age, sex, deprivation, region, scan modality, and pre-scan healthcare, were calculated for each phenotype. ResultsFrom 395,273 people with brain imaging and no history of neurological disease, 145,978 (37%) had [≥]1 phenotype. For each phenotype, the aHR of any stroke was: WMH 1.4 (95%CI: 1.3-1.4), lacunes 1.6 (1.5-1.6), cortical infarct 1.7 (1.6-1.8), and cerebral atrophy 1.1 (1.0-1.1). The aHR of any dementia was: WMH, 1.3 (1.3-1.3), lacunes, 1.0 (0.9-1.0), cortical infarct 1.1 (1.0-1.1) and cerebral atrophy 1.7 (1.7-1.7). The aHR of Parkinsons disease was, in people with a report of: WMH 1.1 (1.0-1.2), lacunes 1.1 (0.9-1.2), cortical infarct 0.7 (0.6-0.9) and cerebral atrophy 1.4 (1.3-1.5). The aHRs between CCD phenotypes and epilepsy and colorectal cancer overlapped the null. Conclusions and RelevanceNLP identified CCD and atrophy phenotypes from routine clinical image reports, and these had important associations with future stroke, dementia and Parkinsons disease. Prevention of neurological disease in people with CCD should be a priority for healthcare providers and policymakers. Key PointsO_ST_ABSQuestionC_ST_ABSAre measures of Covert Cerebrovascular Disease (CCD) associated with the risk of subsequent disease (stroke, dementia, Parkinsons disease, epilepsy, and colorectal cancer)? FindingsThis study used a validated NLP algorithm to identify CCD (white matter hypoattenuation/hyperintensities, lacunes, cortical infarcts) and cerebral atrophy from both MRI and computed tomography (CT) imaging reports generated during routine healthcare in >395K people in Scotland. In adjusted models, we demonstrate higher risk of dementia (particularly Alzheimers disease) in people with atrophy, and higher risk of stroke in people with cortical infarcts. However, associations with an age-associated control outcome (colorectal cancer) were neutral, supporting a causal relationship. It also highlights differential associations between cerebral atrophy and dementia and cortical infarcts and stroke risk. MeaningCCD or atrophy on brain imaging reports in routine clinical practice is associated with a higher risk of stroke or dementia. Evidence is needed to support treatment strategies to reduce this risk. NLP can identify these important, otherwise uncoded, disease phenotypes, allowing research at scale into imaging-based biomarkers of dementia and stroke.

OneTouch Automated Photoacoustic and Ultrasound Imaging of Breast in Standing Pose.

Zhang H, Zheng E, Zheng W, Huang C, Xi Y, Cheng Y, Yu S, Chakraborty S, Bonaccio E, Takabe K, Fan XC, Xu W, Xia J

pubmed logopapersJun 12 2025
We developed an automated photoacoustic and ultrasound breast tomography system that images the patient in the standing pose. The system, named OneTouch-PAT, utilized linear transducer arrays with optical-acoustic combiners for effective dual-modal imaging. During scanning, subjects only need to gently attach their breasts to the imaging window, and co-registered three-dimensional ultrasonic and photoacoustic images of the breast can be obtained within one minute. Our system has a large field of view of 17 cm by 15 cm and achieves an imaging depth of 3 cm with sub-millimeter resolution. A three-dimensional deep-learning network was also developed to further improve the image quality by improving the 3D resolution, enhancing vasculature, eliminating skin signals, and reducing noise. The performance of the system was tested on four healthy subjects and 61 patients with breast cancer. Our results indicate that the ultrasound structural information can be combined with the photoacoustic vascular information for better tissue characterization. Representative cases from different molecular subtypes have indicated different photoacoustic and ultrasound features that could potentially be used for imaging-based cancer classification. Statistical analysis among all patients indicates that the regional photoacoustic intensity and vessel branching points are indicators of breast malignancy. These promising results suggest that our system could significantly enhance breast cancer diagnosis and classification.

Task Augmentation-Based Meta-Learning Segmentation Method for Retinopathy.

Wang J, Mateen M, Xiang D, Zhu W, Shi F, Huang J, Sun K, Dai J, Xu J, Zhang S, Chen X

pubmed logopapersJun 12 2025
Deep learning (DL) requires large amounts of labeled data, which is extremely time-consuming and laborintensive to obtain for medical image segmentation tasks. Metalearning focuses on developing learning strategies that enable quick adaptation to new tasks with limited labeled data. However, rich-class medical image segmentation datasets for constructing meta-learning multi-tasks are currently unavailable. In addition, data collected from various healthcare sites and devices may present significant distribution differences, potentially degrading model's performance. In this paper, we propose a task augmentation-based meta-learning method for retinal image segmentation (TAMS) to meet labor-intensive annotation demand. A retinal Lesion Simulation Algorithm (LSA) is proposed to automatically generate multi-class retinal disease datasets with pixel-level segmentation labels, such that metalearning tasks can be augmented without collecting data from various sources. In addition, a novel simulation function library is designed to control generation process and ensure interpretability. Moreover, a generative simulation network (GSNet) with an improved adversarial training strategy is introduced to maintain high-quality representations of complex retinal diseases. TAMS is evaluated on three different OCT and CFP image datasets, and comprehensive experiments have demonstrated that TAMS achieves superior segmentation performance than state-of-the-art models.

Modality-AGnostic Image Cascade (MAGIC) for Multi-Modality Cardiac Substructure Segmentation

Nicholas Summerfield, Qisheng He, Alex Kuo, Ahmed I. Ghanem, Simeng Zhu, Chase Ruff, Joshua Pan, Anudeep Kumar, Prashant Nagpal, Jiwei Zhao, Ming Dong, Carri K. Glide-Hurst

arxiv logopreprintJun 12 2025
Cardiac substructures are essential in thoracic radiation therapy planning to minimize risk of radiation-induced heart disease. Deep learning (DL) offers efficient methods to reduce contouring burden but lacks generalizability across different modalities and overlapping structures. This work introduces and validates a Modality-AGnostic Image Cascade (MAGIC) for comprehensive and multi-modal cardiac substructure segmentation. MAGIC is implemented through replicated encoding and decoding branches of an nnU-Net-based, U-shaped backbone conserving the function of a single model. Twenty cardiac substructures (heart, chambers, great vessels (GVs), valves, coronary arteries (CAs), and conduction nodes) from simulation CT (Sim-CT), low-field MR-Linac, and cardiac CT angiography (CCTA) modalities were manually delineated and used to train (n=76), validate (n=15), and test (n=30) MAGIC. Twelve comparison models (four segmentation subgroups across three modalities) were equivalently trained. All methods were compared for training efficiency and against reference contours using the Dice Similarity Coefficient (DSC) and two-tailed Wilcoxon Signed-Rank test (threshold, p<0.05). Average DSC scores were 0.75(0.16) for Sim-CT, 0.68(0.21) for MR-Linac, and 0.80(0.16) for CCTA. MAGIC outperforms the comparison in 57% of cases, with limited statistical differences. MAGIC offers an effective and accurate segmentation solution that is lightweight and capable of segmenting multiple modalities and overlapping structures in a single model. MAGIC further enables clinical implementation by simplifying the computational requirements and offering unparalleled flexibility for clinical settings.

Med-URWKV: Pure RWKV With ImageNet Pre-training For Medical Image Segmentation

Zhenhuan Zhou

arxiv logopreprintJun 12 2025
Medical image segmentation is a fundamental and key technology in computer-aided diagnosis and treatment. Previous methods can be broadly classified into three categories: convolutional neural network (CNN) based, Transformer based, and hybrid architectures that combine both. However, each of them has its own limitations, such as restricted receptive fields in CNNs or the computational overhead caused by the quadratic complexity of Transformers. Recently, the Receptance Weighted Key Value (RWKV) model has emerged as a promising alternative for various vision tasks, offering strong long-range modeling capabilities with linear computational complexity. Some studies have also adapted RWKV to medical image segmentation tasks, achieving competitive performance. However, most of these studies focus on modifications to the Vision-RWKV (VRWKV) mechanism and train models from scratch, without exploring the potential advantages of leveraging pre-trained VRWKV models for medical image segmentation tasks. In this paper, we propose Med-URWKV, a pure RWKV-based architecture built upon the U-Net framework, which incorporates ImageNet-based pretraining to further explore the potential of RWKV in medical image segmentation tasks. To the best of our knowledge, Med-URWKV is the first pure RWKV segmentation model in the medical field that can directly reuse a large-scale pre-trained VRWKV encoder. Experimental results on seven datasets demonstrate that Med-URWKV achieves comparable or even superior segmentation performance compared to other carefully optimized RWKV models trained from scratch. This validates the effectiveness of using a pretrained VRWKV encoder in enhancing model performance. The codes will be released.

MedSeg-R: Reasoning Segmentation in Medical Images with Multimodal Large Language Models

Yu Huang, Zelin Peng, Yichen Zhao, Piao Yang, Xiaokang Yang, Wei Shen

arxiv logopreprintJun 12 2025
Medical image segmentation is crucial for clinical diagnosis, yet existing models are limited by their reliance on explicit human instructions and lack the active reasoning capabilities to understand complex clinical questions. While recent advancements in multimodal large language models (MLLMs) have improved medical question-answering (QA) tasks, most methods struggle to generate precise segmentation masks, limiting their application in automatic medical diagnosis. In this paper, we introduce medical image reasoning segmentation, a novel task that aims to generate segmentation masks based on complex and implicit medical instructions. To address this, we propose MedSeg-R, an end-to-end framework that leverages the reasoning abilities of MLLMs to interpret clinical questions while also capable of producing corresponding precise segmentation masks for medical images. It is built on two core components: 1) a global context understanding module that interprets images and comprehends complex medical instructions to generate multi-modal intermediate tokens, and 2) a pixel-level grounding module that decodes these tokens to produce precise segmentation masks and textual responses. Furthermore, we introduce MedSeg-QA, a large-scale dataset tailored for the medical image reasoning segmentation task. It includes over 10,000 image-mask pairs and multi-turn conversations, automatically annotated using large language models and refined through physician reviews. Experiments show MedSeg-R's superior performance across several benchmarks, achieving high segmentation accuracy and enabling interpretable textual analysis of medical images.

Generalist Models in Medical Image Segmentation: A Survey and Performance Comparison with Task-Specific Approaches

Andrea Moglia, Matteo Leccardi, Matteo Cavicchioli, Alice Maccarini, Marco Marcon, Luca Mainardi, Pietro Cerveri

arxiv logopreprintJun 12 2025
Following the successful paradigm shift of large language models, leveraging pre-training on a massive corpus of data and fine-tuning on different downstream tasks, generalist models have made their foray into computer vision. The introduction of Segment Anything Model (SAM) set a milestone on segmentation of natural images, inspiring the design of a multitude of architectures for medical image segmentation. In this survey we offer a comprehensive and in-depth investigation on generalist models for medical image segmentation. We start with an introduction on the fundamentals concepts underpinning their development. Then, we provide a taxonomy on the different declinations of SAM in terms of zero-shot, few-shot, fine-tuning, adapters, on the recent SAM 2, on other innovative models trained on images alone, and others trained on both text and images. We thoroughly analyze their performances at the level of both primary research and best-in-literature, followed by a rigorous comparison with the state-of-the-art task-specific models. We emphasize the need to address challenges in terms of compliance with regulatory frameworks, privacy and security laws, budget, and trustworthy artificial intelligence (AI). Finally, we share our perspective on future directions concerning synthetic data, early fusion, lessons learnt from generalist models in natural language processing, agentic AI and physical AI, and clinical translation.

A strategy for the automatic diagnostic pipeline towards feature-based models: a primer with pleural invasion prediction from preoperative PET/CT images.

Kong X, Zhang A, Zhou X, Zhao M, Liu J, Zhang X, Zhang W, Meng X, Li N, Yang Z

pubmed logopapersJun 12 2025
This study aims to explore the feasibility to automate the application process of nomograms in clinical medicine, demonstrated through the task of preoperative pleural invasion prediction in non-small cell lung cancer patients using PET/CT imaging. The automatic pipeline involves multimodal segmentation, feature extraction, and model prediction. It is validated on a cohort of 1116 patients from two medical centers. The performance of the feature-based diagnostic model outperformed both the radiomics model and individual machine learning models. The segmentation models for CT and PET images achieved mean dice similarity coefficients of 0.85 and 0.89, respectively, and the segmented lung contours showed high consistency with the actual contours. The automatic diagnostic system achieved an accuracy of 0.87 in the internal test set and 0.82 in the external test set, demonstrating comparable overall diagnostic performance to the human-based diagnostic model. In comparative analysis, the automatic diagnostic system showed superior performance relative to other segmentation and diagnostic pipelines. The proposed automatic diagnostic system provides an interpretable, automated solution for predicting pleural invasion in non-small cell lung cancer.

Summary Report of the SNMMI AI Task Force Radiomics Challenge 2024.

Boellaard R, Rahmim A, Eertink JJ, Duehrsen U, Kurch L, Lugtenburg PJ, Wiegers SE, Zwezerijnen GJC, Zijlstra JM, Heymans MW, Buvat I

pubmed logopapersJun 12 2025
In medical imaging, challenges are competitions that aim to provide a fair comparison of different methodologic solutions to a common problem. Challenges typically focus on addressing real-world problems, such as segmentation, detection, and prediction tasks, using various types of medical images and associated data. Here, we describe the organization and results of such a challenge to compare machine-learning models for predicting survival in patients with diffuse large B-cell lymphoma using a baseline <sup>18</sup>F-FDG PET/CT radiomics dataset. <b>Methods:</b> This challenge aimed to predict progression-free survival (PFS) in patients with diffuse large B-cell lymphoma, either as a binary outcome (shorter than 2 y versus longer than 2 y) or as a continuous outcome (survival in months). All participants were provided with a radiomic training dataset, including the ground truth survival for designing a predictive model and a radiomic test dataset without ground truth. Figures of merit (FOMs) used to assess model performance were the root-mean-square error for continuous outcomes and the C-index for 1-, 2-, and 3-y PFS binary outcomes. The challenge was endorsed and initiated by the Society of Nuclear Medicine and Molecular Imaging AI Task Force. <b>Results:</b> Nineteen models for predicting PFS as a continuous outcome from 15 teams were received. Among those models, external validation identified 6 models showing similar performance to that of a simple general linear reference model using SUV and total metabolic tumor volumes (TMTV) only. Twelve models for predicting binary outcomes were submitted by 9 teams. External validation showed that 1 model had higher, but nonsignificant, C-index values compared with values obtained by a simple logistic regression model using SUV and TMTV. <b>Conclusion:</b> Some of the radiomic-based machine-learning models developed by participants showed better FOMs than did simple linear or logistic regression models based on SUV and TMTV only, although the differences in observed FOMs were nonsignificant. This suggests that, for the challenge dataset, there was limited or no value seen from the addition of sophisticated radiomic features and use of machine learning when developing models for outcome prediction.
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