An exploratory clinical trial of preoperative non-invasive localization before breast-conserving surgery using augmented reality technology

Minah Lee; Joohyun Woo; Se Hyun Peak; Hyun Goo Kim; Woo Sung Lim; Jin Chung; Jee Eun Lee; Jeoung Hyun Kim; Sanghui Park; Ji Min Kim; Jun Woo Lee

doi:10.1007/s10549-024-07272-3

An exploratory clinical trial of preoperative non-invasive localization before breast-conserving surgery using augmented reality technology

Breast Cancer Res Treat. 2024 May 14. doi: 10.1007/s10549-024-07272-3. Online ahead of print.

Authors

Affiliations

¹ Department of Radiology, School of Medicine, Ewha Womans University, Seoul, South Korea.
² Division of Breast Surgery, Department of Surgery, School of Medicine, Ewha Womans University, Seoul, South Korea.
³ Department of Pathology, School of Medicine, Ewha Womans University, Seoul, South Korea.
⁴ Division of Breast Surgery, Department of Surgery, School of Medicine, Ewha Womans University, Seoul, South Korea. wnslee@ewha.ac.kr.

PMID: 38743175
DOI: 10.1007/s10549-024-07272-3

Abstract

Purpose: This single-center, randomized, prospective, exploratory clinical trial was conducted to assess the clinical efficacy of an augmented reality (AR)-based breast cancer localization imaging solution for patients with breast cancer.

Methods: This clinical trial enrolled 20 women who were diagnosed with invasive breast cancer between the ages of 19 and 80, had a single lesion with a diameter ≥ 5 mm but ≤ 30 mm, had no metastases to other organs, and had not received prior chemotherapy. All patients underwent mammography, ultrasound, computed tomography, and magnetic resonance imaging for preoperative assessment. Patients were randomly assigned to ultrasound-guided skin marking localization (USL) and AR-based localization (ARL) groups (n = 10 in each group). Statistical comparisons between USL and ARL groups were made based on demographics, radiologic features, pathological outcomes, and surgical outcomes using chi-square and Student t-tests.

Results: Two surgeons performed breast-conserving surgery on 20 patients. Histopathologic evaluation of all patients confirmed negative margins. Two independent pathologists evaluated the marginal distances, and there were no intergroup differences in the readers' 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) or the readers' average values (5.65 ± 4.19 vs. 4.57 ± 2.84, P = 0.509). In comparing the tumor plane area ratio, there was no statistically significant difference between the two groups in terms of either reader's mean values (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) or the overall mean values of two readers combined (15.56 ± 9.11 vs. 20.09 ± 13.38, P = 0.388). Convenience, safety, satisfaction, and reusability were all superior in the AR localization group (P < 0.001) based on the two surgeons' responses.

Conclusion: AR localization is an acceptable alternative to ultrasound-guided skin marking with no significant differences in surgical outcomes.

Keywords: 3D breast model; Augmented reality; Breast cancer; Breast conservative surgery.