Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Recruiting now · Not applicable

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT07003841

Run by

SKIA Inc.

People needed

94

Starts

2025-11-19

Expected to finish

2027-03-31

Last updated by the study team

2026-03-12

Who can join

Age: 19 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects will be excluded from enrollment if they meet any of the exclusion criteria.
• Subjects prohibited from both MRI, CT and Ultrasound scans.
• Subjects with no lesions visible on CT.
• Pregnant or lactating(i.e., breastfeeding) subjects.
• Subjects who are biologically male.
• Subjects with breast cancer who received neoadjuvant chemotherapy or who have metastasized to other organs
• Subjects whose biopsy pathology results are Invasive lobular carcinoma
• Subjects deemed unsuitable for the study according to judgment of the investigator

Where it is running

• Ewha Womans University Medical Center — Seoul, Gangseo-gu, South Korea (enrolling)
• Seoul National University Hospital — Seoul, Jongno-gu, South Korea (enrolling)
• Yonsei University Health System, Severance Hospital — Seoul, Seodaemun-gu, South Korea (enrolling)

Full record on ClinicalTrials.gov

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