RecruitingNot ApplicableNCT07003841

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

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

Sponsor

SKIA Inc.

Enrollment

94 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

Summary

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.

Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 80 Years

Inclusion Criteria7

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 Criteria7

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

Interventions

DEVICESurgical 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

DEVICEGeneral 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.