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

NCT ID: NCT07003841

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-03-31

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ultrasound Skin Marking Group

Mastectomy will be performed after applying the ultrasound skin marking method

Group Type: ACTIVE_COMPARATOR

General ultrasound imaging system

Intervention Type: 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.

AR-based Imaging Group

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

Group Type: EXPERIMENTAL

Surgical navigation system with stereotactic guidance

Intervention Type: 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

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

SKIA-Breast

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SKIA Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ewha Womans University Medical Center

Seoul, Gangseo-gu, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, South Korea

Countries

South Korea

Central Contacts

Jeongmi LEE

Role: CONTACT

jmlee@skia.kr

+821048856620

Facility Contacts

Ewha Womans University Medical Center

Role: primary

jmlee@skia.kr

+82 02-2650-5893

Seoul National University Hospital

Role: primary

jmlee@skia.kr

+820880721958

Yonsei University Health System, Severance Hospital

Role: primary

jmlee@skia.kr

+8222282134

Other Identifiers

S_SKIAB_P02

Identifier Type: -

Identifier Source: org_study_id