Breast Neoplasms
Conditions
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.
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.
Sponsors
SKIA Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative margin resection rate | within 4week after biopsy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| re-excision rate | within 4week after biopsy | Re-excision rate due to positive margins assessed by histopathological examination |
| margin assessment | within 4week after biopsy | In breast resections performed after the application of the investigational medical device, pathological assessment of the resection margins will be conducted by an independent evaluator (pathologist). Only the lateral, medial, superior, and inferior directions will be recorded, while the deep and superficial margins will be excluded. For analysis, the minimum value among the four recorded margins will be selected and classified into the following six categories: 1. Less than 2 mm 2. 2 mm to less than 5 mm 3. 5 mm to less than 10 mm 4. 10 mm to less than 20 mm 5. 20 mm to less than 30 mm 6. 30 mm or greater |
| 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. |
Countries
South Korea
Contacts
CONTACTJeongmi LEE
Outcome results
None listed