Preoperative prediction of positive margins in breast-conserving surgery using an ensemble model based on DCE-MRI: a multi-center retrospective and prospective study

BACKGROUND: Breast-conserving surgery (BCS) is the standard care for early breast cancer. However, positive surgical margins lead to high recurrence and require reoperation, remaining a clinical challenge. This study aims to develop an ensemble model to preoperatively predict positive margins using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). METHODS: A total of 887 patients from three Chinese medical centers were included. Patients from the Yunnan (581 patients) and Fujian (51 patients) provinces were used for model development, with external testing on 188 patients from Guangdong and prospective testing on 67 patients from Yunnan. Three base models were developed: the clinical model based on 32 features, the deep learning (DL) model using ResNet-34, and the radiomics model utilizing radiomics features. The ensemble model combined predictions from these three base models using weighted voting. Performance metrics (accuracy, AUC, sensitivity, specificity) were computed, and prognostic analyses were conducted with a public dataset. RESULTS: The ensemble model outperformed each of the three base models, with the AUC of 0.931, accuracy of 0.872, sensitivity of 0.871, and specificity of 0.880 in the validation set. Robustness was further confirmed in independent test cohorts, yielding AUCs of 0.762 and 0.861. Furthermore, patients identified at high-risk by the model exhibited poor recurrence-free survival (RFS, HR = 8.117, p < 0.0001) and overall survival (OS, HR = 5.748, p < 0.0001), underscoring its prognostic value. CONCLUSIONS: The ensemble model based on DCE-MRI effectively predicts positive margins and prognosis for BCS patients, facilitating the clinical decision-making on the surgery. Trial registration This study was approved by the Ethics Committee of the Yunnan Cancer Hospital (KYLX2023-134), Xiang'an Hospital of Xiamen University (XDYX202305K26), and Cancer Hospital of Shantou University Medical College (2024059). The study was also registered with the Chinese Clinical Trial Registry (ChiCTR2400083298, Registered 19 April 2024, https://www.chictr.org.cn/showproj.html?%20proj=207948 ).