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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

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…

ClinicalTrials.gov IDNCT07003841

PhaseNA

Enrollment94

SponsorSKIA Inc.

Age19 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Neoplasms

About this study

Interventions

Device: Surgical navigation system with stereotactic guidance — This investigational medical software device utilizes CT imaging data to project the scanned anatomy onto the patient's body, enabling augmented reality-based visualization of the lesion site before surgery
Device: General ultrasound imaging system — A general diagnostic ultrasound imaging device that transmits ultrasound energy to the lesion for diagnostic purposes and visualizes the reflected signals. It supports various types of transducers and associated application software packages used for acquiring, displaying, and analyzing ultrasound data.

Primary outcomes

Negative margin resection rate (within 4week after biopsy)

Eligibility information

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

Study locations

Ewha Womans University Medical Center, Seoul, Gangseo-gu 07804 South Korea
Seoul National University Hospital, Seoul, Jongno-gu South Korea
Yonsei University Health System, Severance Hospital, Seoul, Seodaemun-gu South Korea

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.