Abstract
Conventional methods for breast tumor margins assessment need a long turnaround time, which may lead to re-operation for patients undergoing lumpectomy surgeries. Photoacoustic tomography (PAT) has been shown to visualize adipose tissue in small animals and human breast. Here, we demonstrate a customized multimodal ultrasound and PAT system for intraoperative breast tumor margins assessment using fresh lumpectomy specimens from 66 patients. The system provides the margin status of the entire excised tissue within 10 minutes. By subjective reading of three researchers, the results show 85.7% [95% confidence interval (CI), 42.0% - 99.2%] sensitivity and 84.6% (95% CI, 53.7% - 97.3%) specificity, 71.4% (95% CI, 30.3% - 94.9%) sensitivity and 92.3% (95% CI, 62.1% - 99.6%) specificity, and 100% (95% CI, 56.1% - 100%) sensitivity and 53.9% (95% CI, 26.1% - 79.6%) specificity respectively when cross-correlated with post-operational histology. Furthermore, a machine learning-based algorithm is deployed for margin assessment in the challenging ductal carcinoma in situ tissues, and achieved 85.5% (95% CI, 75.2% - 92.2%) sensitivity and 90% (95% CI, 79.9% - 95.5%) specificity. Such results present the potential of using mutlimodal ultrasound and PAT as a high-speed and accurate method for intraoperative breast tumor margins evaluation.
Highlights
Each year, there are ~249,000 newly-diagnosed breast cancer cases in the United States, 70% of which undergo breast-conserving surgery, or lumpectomy [1]
We designed a tissue cartridge and tissue container to prepare the tissue for scanning and reconstruct 3D images within 5 minutes in 4 steps: 1) Before the imaging, the fresh excised breast tissue is rinsed by 0.9% saline solution, which takes 1 minute; 2) Ultrasound gel is applied on the surface of the tissue, which takes less than 1.5 minutes; 3) The tissue cartridge with the tissue was inserted into the imaging chamber, which takes less than 0.5 minute; 4) By pressing one button, the tissue surface was scanned within 2 minutes
We demonstrate the first application of a customized mutlimodal ultrasound and Photoacoustic tomography (PAT) system for intraoperative breast tumor margins assessment using a compact and portable Raman-laser-based system and fresh lumpectomy specimens from 66 patients
Summary
There are ~249,000 newly-diagnosed breast cancer cases in the United States, 70% of which undergo breast-conserving surgery, or lumpectomy [1]. The ability to obtain accurate intraoperative feedback about margin status will reduce the need for re-excision and surgery related cost. Radio frequency spectroscopy reduces the procedure time, but still suffers from limited sensitivity (70%) and specificity (68%) owning to the lack of chemical selectivity [15,16]. The emerging optical technologies, including optical coherence tomography (OCT), Raman spectroscopy, and diffuse reflectance imaging have improved the sensitivity and specificity, but still suffer from long procedure time, inadequate imaging depth, or limited detection area [19,20,21,22]. An unmet need exists in developing an intraoperative margin assessment tool that is rapid, accurate, and able to measure the entire tissue surface with adequate imaging depth [22,23]
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