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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jmlee@skia.kr
• Phone: +821048856620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.