Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients
Recruiting · NCT07003841 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed.
- 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