Actively Recruiting
Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients
Led by SKIA Inc. · Updated on 2026-03-12
94
Participants Needed
3
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 19 to 80 years diagnosed with breast cancer by biopsy
- Patients who have had MRI, CT, and ultrasound scans
- Scheduled for breast-conserving surgery without prior neoadjuvant chemotherapy and no metastasis to other organs
- Tumor size between 5 mm and 30 mm on ultrasound
- Biopsy pathology confirms invasive carcinoma
- Presence of a single breast lesion
- Patients who understand the study and provide written informed consent
You will not qualify if you...
- Patients unable to undergo MRI, CT, or ultrasound scans
- No visible lesions on CT scan
- Pregnant or breastfeeding women
- Male patients
- Patients who received neoadjuvant chemotherapy or have cancer spread to other organs
- Biopsy pathology shows invasive lobular carcinoma
- Patients deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Ewha Womans University Medical Center
Seoul, Gangseo-gu, South Korea, 07804
Actively Recruiting
2
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Actively Recruiting
3
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, South Korea
Actively Recruiting
Research Team
J
Jeongmi LEE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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