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

NCT07003841 | Recruiting

• 1 other identifier: S_SKIAB_P02
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Negative margin resection rate

  Each subject will have one surgical margin evaluated, with an independent pathologist determining margin status (negative or positive) based on the permanent postoperative pathology specimen. Measurements of the margin are taken in the medial, lateral, superior, and inferior directions in millimeters, with conservative rounding applied to decimal values.

  within 4week after biopsy

Secondary Outcomes (4)

• re-excision rate

  within 4week after biopsy

• margin assessment

  within 4week after biopsy

• Tumor-to-gross area ratio of excised tissue

  within 4week after biopsy

• User satisfaction

  on the day of biopsy

Study Arms (2)

Ultrasound Skin Marking Group

ACTIVE COMPARATOR

Mastectomy will be performed after applying the ultrasound skin marking method

Device: General ultrasound imaging system

AR-based Imaging Group

EXPERIMENTAL

Mastectomy will be performed after applying the localization method using the augmented reality-based medical imaging solution

Device: Surgical navigation system with stereotactic guidance

Interventions

Surgical navigation system with stereotactic guidance DEVICE

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

Also known as: SKIA-Breast

AR-based Imaging Group

General ultrasound imaging system DEVICE

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.

Ultrasound Skin Marking Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SKIA Inc.: lead

Study Sites (3)

Ewha Womans University Medical Center

Seoul, Gangseo-gu, 07804, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Navigation Systems

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Central Study Contacts

Jeongmi LEE

CONTACT

+821048856620; jmlee@skia.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigational device and the control device used in this clinical trial have distinctly different appearances, making it impossible to maintain blinding of the investigators and participants; therefore, the trial will be conducted with blinding of an independent evaluator only
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 4, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)