NCT07003841 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SKIA Inc. |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2025-11-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07003841 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 80 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07003841 currently recruiting?
Yes, NCT07003841 is actively recruiting participants. Contact the research team at jmlee@skia.kr for enrollment information.
Where is the NCT07003841 trial being conducted?
This trial is being conducted at Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07003841 clinical trial?
NCT07003841 is sponsored by SKIA Inc.. The trial plans to enroll 94 participants.