Breast NeoplasmsNCT07003841
Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients
A study testing Surgical navigation system with stereotactic guidance and General ultrasound imaging system in people with Breast Neoplasms, run by SKIA Inc. at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Surgical navigation system with stereotactic guidance and General ultrasound imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 19 Nov 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Ewha Womans University Medical Center
Seoul, Gangseo-gu, 07804
Ewha Womans University Medical Center, +82 02-2650-5893, jmlee@skia.kr
Woosung Lim
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu
Seoul National University Hospital, +820880721958, jmlee@skia.kr
Wonshik Han
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu
Yonsei University Health System, Severance Hospital, +8222282134, jmlee@skia.kr
Seho Park
About this study
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
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.
Read the detailed description
- 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.
- 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.
- 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
- Being tested
- Surgical navigation system with stereotactic guidance, General ultrasound imaging system
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical navigation system with stereotactic guidanceDevice
Also called SKIA-Breast
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
General ultrasound imaging systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Skin Marking Group | Active comparator | Mastectomy will be performed after applying the ultrasound skin marking method Receives: 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 Receives: Device: Surgical navigation system with stereotactic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 4week after biopsy
Secondary outcomes (4)
re-excision rate
Re-excision rate due to positive margins assessed by histopathological examination
Measured: within 4week after biopsy
margin assessment
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:
- Less than 2 mm
- 2 mm to less than 5 mm
- 5 mm to less than 10 mm
- 10 mm to less than 20 mm
- 20 mm to less than 30 mm
- 30 mm or greater
Measured: within 4week after biopsy
Tumor-to-gross area ratio of excised tissue
Tumor-to-gross area ratio of excised tissue (excluding thickness) assessed by histopathology.
Calculation formula: (Tumor surface area / Gross (tumor + margin) surface area) × 100 (%)
Measured: within 4week after biopsy
User satisfaction
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.
Measured: on the day of biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start19 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SKIA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003841
- Sponsor's protocol ID
- S_SKIAB_P02
- Status last verified
- Mar 2026
- First submitted
- 26 May 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07003841
- Acronym / sponsor ID
- S_SKIAB_P02
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- SKIA Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Skin Marking Group | Active comparator | Device: General ultrasound imaging systemMastectomy will be performed after applying the ultrasound skin marking method |
| AR-based Imaging Group | Experimental | Device: Surgical navigation system with stereotactic guidanceMastectomy will be performed after applying the localization method using the augmented reality-based medical imaging solution |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be enrolled only when all the inclusion criteria are fully met.
Key exclusion criteria (8 listed)
- Subjects will be excluded from enrollment if they meet any of the exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical navigation system with stereotactic guidanceAlso: SKIA-BreastThis 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 | AR-based Imaging Group |
| General ultrasound imaging systemA 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. | Device | Ultrasound Skin Marking Group |
Primary outcome
Negative margin resection rate
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical navigation system with stereotactic guidance and General ultrasound imaging system in people with Breast Neoplasms, run by SKIA Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeongmi LEE (+821048856620, jmlee@skia.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative margin resection rate (time frame: within 4week after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.