Multicenter, Randomized, Controlled, Prospective, Confirmatory Study to Evaluate the Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients Confidential Statement
This clinical trial aims to evaluate whether an augmented reality (AR)-based medical imaging solution (SKIA-Breast) is non-inferior to conventional ultrasound-guided skin marking in guiding breast-conserving surgery in female patients with breast cancer. Participants will be randomly assigned in a 1:1 ratio to either the AR-based group or the conventional group. All participants will undergo breast-conserving surgery according to their assigned method. The primary outcome is the negative margin resection rate evaluated by histopathological examination. The secondary outcome is the re-excision rate due to positive margins assessed by histopathological examination.
• Subjects will be enrolled only when all the inclusion criteria are fully met.
‣ Subjects who aged 19 to 80 years diagnosed with breast cancer through biopsy.
⁃ Subjects diagnosed with breast cancer who had both MRI and CT and ultrasound scans.
⁃ Patients diagnosed with breast cancer who are scheduled to undergo breast-conserving surgery, have not received neoadjuvant chemotherapy, and show no evidence of metastasis to other organs.
⁃ Tumor size criteria on ultrasound: : 5 mm ≤ tumor size ≤ 30 mm
⁃ Subjects whose biopsy pathology results are Invasive carcinoma.
⁃ Subjects who have a single lesion.
⁃ Subjects who have received a full explanation of the clinical trial fully understand its details, voluntarily decide to participate, and provide written informed consent.