Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

Surgical 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

General 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.

Study 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

Primary outcome measure(s)

• 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.

Trial sites (3)

Other trials for the same condition