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Abstract Purpose: A single-center, randomized, prospective exploratory clinical trial to assess the clinical efficacy of augmented reality(AR)-based breast cancer localization medical imaging solution in patients with breast cancer Methods: This prospective exploratory clinical trial enrolled 20 women who were diagnosed with invasive breast cancer between the ages of 19 and 70, had a single lesion or multifocal lesion with a lesion size of 5mm or more and 30mm or less, had no metastasis to other organs, and had not received prior chemotherapy. All patients underwent mammography, ultrasound, CT, and MRI for preoperative assessment. Patients were randomly assigned to US-guided skin marking (control) and SKIA-breast (AR localization) groups of 10 each. Result: Two surgeons performed breast-conserving surgery on twenty patients. Pathologic evaluation of all patients confirmed negative margins. Two independent pathologists evaluated marginal distance, and neither the two reader's estimates (R1, 6.20±4.37 vs. 5.04±3.47, p=0.519; R2, 5.10±4.31 vs. 4.10±2.38, p= 0.970) nor the two reader's average values (5.65±4.19 vs. 4.57±2.84, p= 0.509) showed any difference between the two groups. In comparing the tumor plane area ratio, there was no statistically significant difference between the two groups for the two readers (R1, 15.90±9.52 vs. 19.38±14.05, p=0.525; R2, 15.32±9.48 vs. 20.83±12.85, p=0.290) and the two reader's mean values (15.56±9.11 vs. 20.09±13.38, p=0.388). Based on the two surgeons' responses, convenience, safety, satisfaction, and reusability were all superior in the AR localization group (p=0.000). Conclusion: AR localization is an acceptable alternative to US-guided skin marking with no significant differences in surgical outcomes. Citation Format: Minah Lee, Jun Woo Lee, Woosung Lim, Joohyun Woo, Hyun-Goo Kim, Se Hyun Paek, SangHui Park, Ji Min Kim, Jin Chung, Jee Eun Lee, Jeoung Hyun Kim. Exploratory clinical trial of preoperative non-invasive localization before surgery in breast cancer patients using augmented reality technology abstract. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-23-05.
Lee et al. (Thu,) studied this question.