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

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new technology called SKIA-Breast that uses augmented reality (AR) to help surgeons more precisely locate and remove breast cancer tumors during breast-conserving surgery. It compares this AR-based approach to standard tumor localization methods. **You may be eligible if...** - You are a woman aged 19 to 80 with a biopsy-confirmed breast cancer diagnosis - You have had both MRI and CT and ultrasound imaging of your breast - You are scheduled for breast-conserving surgery (lumpectomy) and have not had neoadjuvant chemotherapy - Your tumor is between 5 mm and 30 mm on ultrasound - You have invasive carcinoma (not invasive lobular carcinoma) - You have a single tumor lesion with no spread to other organs **You may NOT be eligible if...** - You cannot have MRI, CT, or ultrasound scans - Your tumor is not visible on CT - You are pregnant or breastfeeding - You have invasive lobular carcinoma - You received neoadjuvant chemotherapy or have cancer that has spread to other organs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.