Augmented reality (SKIA-Breast) localization for guiding breast-conserving surgery

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

The trial will test whether an augmented reality system (SKIA-Breast) can guide breast-conserving surgery as well as conventional ultrasound skin marking for women with a single, biopsy-proven invasive breast tumor 5–30 mm in size.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 19 Years to 80 Years
• Sex: Female
• Sponsor: SKIA Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Seoul, Gangseo-gu and 2 other locations)
• Trial ID: NCT07003841 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized 1:1 trial compares an AR-based imaging localization method (SKIA-Breast) to conventional ultrasound-guided skin marking for women undergoing breast-conserving surgery. Eligible participants are women aged 19–80 with a single invasive breast tumor sized 5–30 mm who have undergone MRI, CT, and ultrasound and have not received neoadjuvant chemotherapy. Surgeons will use the assigned localization method during the operation, and the primary endpoint is the negative margin resection rate determined by histopathology, with re-excision rate as a secondary outcome. The trial is conducted across several tertiary centers in Seoul to test non-inferiority of the AR guidance versus standard ultrasound skin marking.

Who should consider this trial

Good fit: Ideal candidates are women 19–80 years old with a single, biopsy-confirmed invasive breast cancer measuring 5–30 mm who are scheduled for breast-conserving surgery, have no distant metastases, and have undergone MRI, CT, and ultrasound.

Not a fit: Patients with multifocal disease, tumors smaller than 5 mm or larger than 30 mm, those who received neoadjuvant chemotherapy, have distant metastases, or cannot undergo MRI/CT/ultrasound are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, SKIA-Breast could provide real-time, non-invasive tumor visualization that maintains or improves negative margin rates and reduces the need for re-excision.

How similar studies have performed: Small feasibility and pilot studies of AR-guided surgical navigation in other surgical fields and preliminary breast applications have shown promise, but randomized evidence in breast-conserving surgery remains limited.

Eligibility criteria

Inclusion Criteria:

* Subjects will be enrolled only when all the inclusion criteria are fully met.

  1. Subjects who aged 19 to 80 years diagnosed with breast cancer through biopsy.
  2. Subjects diagnosed with breast cancer who had both MRI and CT and ultrasound scans.
  3. 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.
  4. Tumor size criteria on ultrasound: : 5 mm ≤ tumor size ≤ 30 mm
  5. Subjects whose biopsy pathology results are Invasive carcinoma.
  6. Subjects who have a single lesion.
  7. Subjects who have received a full explanation of the clinical trial fully understand its details, voluntarily decide to participate, and provide written informed consent.

Exclusion Criteria:

* Subjects will be excluded from enrollment if they meet any of the exclusion criteria.

  1. Subjects prohibited from both MRI, CT and Ultrasound scans.
  2. Subjects with no lesions visible on CT.
  3. Pregnant or lactating(i.e., breastfeeding) subjects.
  4. Subjects who are biologically male.
  5. Subjects with breast cancer who received neoadjuvant chemotherapy or who have metastasized to other organs
  6. Subjects whose biopsy pathology results are Invasive lobular carcinoma
  7. Subjects deemed unsuitable for the study according to judgment of the investigator

Where this trial is running

Seoul, Gangseo-gu and 2 other locations

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

Study contacts

• Study coordinator: Jeongmi LEE

Conditions Breast Neoplasms