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

Official title

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

Overview

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.

Interventions

• Device 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
• 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.

Primary outcome measures

• Negative margin resection rate [Time frame: within 4week after biopsy]

Secondary outcome measures (4)

• re-excision rate [Time frame: within 4week after biopsy]
• margin assessment [Time frame: within 4week after biopsy]
• Tumor-to-gross area ratio of excised tissue [Time frame: within 4week after biopsy]
• User satisfaction [Time frame: on the day of biopsy]

Eligibility criteria

Inclusion criteria

• Subjects will be enrolled only when all the inclusion criteria are fully met.

• 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 criteria

• Subjects will be excluded from enrollment if they meet any of the exclusion criteria.

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

South Korea · 3 centers

• Ewha Womans University Medical Center — Seoul
• Seoul National University Hospital — Seoul
• Yonsei University Health System, Severance Hospital — Seoul

Identifiers

NCT: NCT07003841 · S_SKIAB_P02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗