Study Protocol for Assessment of the Feasibility of an Intraoperative Localization Technique Using Augmented Reality in Breast-Conserving Surgery for Non-Palpable Cancer Lesions: A Feasibility Study.

Background and Aims: Localizing non-palpable cancerous lesions of breast-conserving surgery is a major challenge. Augmented reality (AR) and 3D imaging are emerging tools for surgical guidance. This study evaluates the feasibility of a noninvasive intraoperative localization technique using AR. Methods: This prospective, interventional, single-center proof-of-concept study investigates AR-assisted localization of non-palpable breast lesions. Secondary objectives include surgical time assessment, breast phantom development, and fusion feasibility between supine 3D breast MRI images and post-MRI ultrasound with target lesion detection. The study includes an additional MRI in supine position and intraoperative 3D images of the patient's chest captured with a 3D camera. A 3D reconstruction of the patient's chest and lesions will be performed from the MRI images, called the preoperative 3D model. A total of five patients eligible for assessment are expected. Conclusion: The challenge of this study is the development of a noninvasive intraoperative localization technique using AR from preoperative images in breast-conserving surgery. If this study is successful, a randomized trial will be designed to compare the accuracy of the intraoperative localization technique using AR with that of the gold standard intraoperative breast ultrasound.