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

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About this study

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.

Condition
Breast Neoplasms
Tested
Surgical navigation system with stereotactic guidance, General ultrasound imaging system
Sponsor
SKIA Inc.

Who can join

Age
19 to 80 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 12

  • Minimum age: 19 years
  • Maximum age: 80 years
  • Eligible sex: Female
  • Study condition: Breast Neoplasms
  • 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.

Exclusion 8

  • 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

3 sites, 3 recruiting

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

Contact

Potential match only. Final eligibility is determined by the study team.