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

Not Applicable

Not yet recruiting

• Conditions: Breast Neoplasms

• Registration Number: NCT07003841
• Lead Sponsor: SKIA Inc.

Brief 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.

Detailed Description

1. Background With the increasing incidence of early breast cancer due to advancements in diagnostic imaging and screening, breast-conserving surgery (BCS) has become more common, offering improved patient satisfaction and quality of life. Accurate lesion localization is critical for successful BCS. While several localization techniques exist, no single method is widely standardized. Augmented reality (AR) presents a promising non-invasive alternative, enabling real-time visual projection of lesion and lymph node positions onto the skin, potentially improving surgical accuracy and addressing limitations of conventional methods.

2. Purpose This study aims to evaluate the clinical efficacy of an AR-based medical imaging localization method (SKIA-Breast) compared to conventional ultrasound-guided skin marking in patients diagnosed with breast cancer who require breast-conserving surgery.

3. Procedure This multicenter, randomized, controlled clinical trial will assess whether the AR-based medical imaging solution (SKIA-Breast) is non-inferior to conventional ultrasound-guided skin marking in guiding breast-conserving surgery. Female patients with breast cancer 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Study Start: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Negative margin resection rate	within 4week after biopsy	Each Subjects will have one surgical margin evaluated, and an independent pathologist will assess the margin status (negative or positive) based on the permanent postoperative pathology specimen

Secondary Outcome Measures

Name	Time	Method
re-excision rate	within 4week after biopsy	Re-excision rate due to positive margins assessed by histopathological examination
margin assessment	within 4week after biopsy	Classification of the minimum margin distance assessed by histopathological examination
Tumor-to-gross area ratio of excised tissue	within 4week after biopsy	Tumor-to-gross area ratio of excised tissue (excluding thickness) assessed by histopathology.; Calculation formula: (Tumor surface area / Gross (tumor + margin) surface area) × 100 (%)
User satisfaction	on the day of biopsy	User satisfaction is assessed in the investigator's survey covering usability, safety, overall satisfaction, and reusability. This satisfaction is measured using a 5-point Likert scale, where higher scores indicate greater satisfaction following the application of the investigational medical device.

Trial Locations

Locations (3)

Ewha Womans University Medical Center; 🇰🇷 Seoul, Gangseo-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of