Purpose: Surgeons and radiologists use 2D radiography during breast conserving surgery (BCS) to evaluate the specimens, but 2D image is inaccurate in assessing the specimen margins. Recently, we presented that a newly developed 3D imagers showed promising results in predicting specimen margins in 21 retrospective cases. However, more samples and further assessment are needed to investigate the application of this new imager in the OR. Therefore, we aimed to explore implementation and potentials of this 3D imager as a new specimen assessment technique during surgery.
Materials and Methods: 1. Review the underlying concept of physical properties, safety, and imaging parameters of the new 3D imager. 2. Evaluate the clinical application of the system in the OR. 3. Assess preliminary results of the 3D imager in predicting the specimen in 100 cases. Patients who undergo BCS are prospectively included. After excision, each specimen is marked for orientation and imaged using 2D radiography first and then 3D imaging during surgery. 3D imaging time and effect on clinical flow are recorded. One blinded radiologist retrospectively analyzes 3D images. The lesion maximal dimension is measured and compared with the diagnostic images and pathology reports. The effect of the breast density, lesion type and size on the prediction will be analyzed. Statistical analyses of the present study is performed using SPSS software.
Results: 1. This new 3D imager is safe and easy to operate in the OR. The imaging processing software is user friendly. 2. The imaging acquisition and processing time is less than 10 minutes and can be integrated into the OR without interruption. However, additional work needs to be done to integrate these new images into the PACS system. 3. Currently, the 3D specimen images in 61 patients have been collected. Giving that this is ongoing project, we haven’t analyzed the collected data. Based on our experience, we will be able to collect 100 samples and analyze them before the final presentation.
Conclusion: The new 3D imager is a promising new technique that could potentially be used for specimen assessment during BCS without interrupting the workflow. The results of this ongoing study will show the accuracy of this 3D imager in predicting specimen margins.
Clinical Relevance Statement: This new 3D imager provides full-3D and thin-slice cross-sectional images and has potential to improve the intraoperative specimen assessment. The protocol established from this study will help guide a perspective clinical trial to evaluate the clinical application of this new technique.
.jpg "Xiaoqin Jennifer Wang, MD photo")