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Tests treatment safety and results for Breast Neoplasms
Official title Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients
ClinicalTrials.gov ID: NCT07003841
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80, women only
You may be able to join if
- people will be enrolled only when all the are fully met.
- people who aged 19 to 80 years diagnosed with breast cancer through biopsy.
- people 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...
- Tumor size criteria on ultrasound: : 5 mm ≤ tumor size ≤ 30 mm
You likely can't join if
- people will be excluded from enrollment if they meet any of the exclusion criteria.
- people prohibited from both MRI, CT and Ultrasound scans.
- people with no lesions visible on CT.
- Pregnant or lactating(i.e., breastfeeding) people.
- people who are biologically male.
- people with breast cancer who received neoadjuvant chemotherapy or who have metastasized to other organs
See the full eligibility criteria
- people will be enrolled only when all the are fully met.
- people who aged 19 to 80 years diagnosed with breast cancer through biopsy.
- people 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
- people whose biopsy pathology results are Invasive carcinoma.
- people who have a single lesion.
- people who have received a full explanation of the clinical trial fully understand its details, voluntarily decide to participate, and provide written informed consent.
- people will be excluded from enrollment if they meet any of the exclusion criteria.
- people prohibited from both MRI, CT and Ultrasound scans.
- people with no lesions visible on CT.
- Pregnant or lactating(i.e., breastfeeding) people.
- people who are biologically male.
- people with breast cancer who received neoadjuvant chemotherapy or who have metastasized to other organs
- people whose biopsy pathology results are Invasive lobular carcinoma
- people deemed unsuitable for the study according to judgment of the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Gangseo-gu, South Korea
- Seoul, Jongno-gu, South Korea
- Seoul, Seodaemun-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Gangseo-gu, South Korea; Seoul, Jongno-gu, South Korea; Seoul, Seodaemun-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.