Less Contouring, More Accuracy: Lesion-Guided ROI Deep Learning for Ovarian Ultrasound Classification

Ovarian cancer is the deadliest gynecological malignancy; accurate and objective segmentation of adnexal masses and functional ovaries in ultrasound (US) remains challenging due to operator variability and morphological complexity. We present OvAi Focus (SynDiag s.r.l., Italy), a stand-alone AI software medical device that performs multi-class semantic segmentation of functional ovaries and adnexal masses, distinguishing cystic from solid components. The system was trained and independently validated on a multicenter dataset of 1,081 adult women from 6 centers across Italy and Israel. Segmentation achieved DICE scores of 0.87 (complete lesion), 0.85 (cystic), 0.68 (solid), and 0.62 (functional ovary), in line with or superior to state-of-the-art approaches across heterogeneous acquisition settings.

The unrestrained proliferation of cells that are malignant in nature is cancer. In recent times, medical professionals are constantly acquiring enhanced diagnostic and treatment abilities by implementing deep learning models to analyze medical data for better clinical decision, disease diagnosis and drug discovery. A majority of cancers are studied and treated by incorporating these technologies. However, ovarian cancer remains a dilemma as it has inaccurate non-invasive detection procedures and a time consuming, invasive procedure for accurate detection. Thus, in this research, several Convolutional Neural Networks such as LeNet-5, ResNet, VGGNet and GoogLeNet/Inception have been utilized to develop 15 variants and choose a model that accurately detects and identifies ovarian cancer. For effective model training, the dataset OvarianCancer&SubtypesDatasetHistopathology from Mendeley has been used. After constructing a model, we utilized Explainable Artificial Intelligence (XAI) models such as LIME, Integrated Gradients and SHAP to explain the black box outcome of the selected model. For evaluating the performance of the model, Accuracy, Precision, Recall, F1-Score, ROC Curve and AUC have been used. From the evaluation, it was seen that the slightly compact InceptionV3 model with ReLu had the overall best result achieving an average score of 94% across all the performance metrics in the augmented dataset. Lastly for XAI, the three aforementioned XAI have been used for an overall comparative analysis. It is the aim of this research that the contributions of the study will help in achieving a better detection method for ovarian cancer.

Background: Automating clinical guideline-based decision-making with large language models (LLMs) remains challenging because of reliability, hallucination, and limited interpretability. We compared the performance of LLMs and reasoning strategies for automated Ovarian-Adnexal Reporting and Data System (O-RADS) classification from free-text pelvic ultrasound reports. Methods: In this retrospective study, consecutive patients with ovarian masses who underwent pelvic ultrasound were included. Eight LLMs were tested with three reasoning strategies: implicit-knowledge end-to-end, rule-informed end-to-end, and a feature-based hybrid architecture that decoupled feature extraction from rule-based classification. The reference standard was O-RADS categorization established by expert consensus. Results: A total of 310 women with 390 ovarian masses were evaluated. The feature-based hybrid architecture using Gemini 3.6 Flash demonstrated the best performance, achieving an accuracy of 99.2% (387 of 390) and almost perfect agreement with the reference standard (weighted kappa = 1.00; 95% CI: 0.99-1.00). Its performance surpassed that of original clinical reports (accuracy, 87.7% [342 of 390]; weighted kappa = 0.94; 95% CI: 0.91-0.96) and end-to-end LLM strategies (accuracy range, 65.6% [256 of 390] to 95.9% [374 of 390]). For structured feature extraction, Gemini 3.6 Flash demonstrated higher overall accuracy than Claude Fable 5 (98.9% vs 97.8%; P < 0.001). The hybrid architecture reduced misclassification errors and mitigated the overstaging tendency observed in original reports. Conclusion: The feature-based hybrid LLM architecture that separates clinical feature extraction from deterministic guideline execution enables highly accurate, reliable, and interpretable automated O-RADS classification, providing a promising approach for standardized, guideline-based clinical decision-making.