A clinical feasibility study of a photoacoustic finder for sentinel lymph node biopsy in breast cancer patients: A prospective cross-sectional study

The sentinel lymph node (SLNb) is generally performed using radioisotopes, blue dyes, or both to improve false negative rate. However, ionizing radiation is involved in a gamma probe with radioisotopes and the blue dye detection relies on native visual inspection by an operator. To overcome these limitations, we developed the photoacoustic finder (PAF), a highly sensitive, non-radioactive detector that uses only blue dye and a photoacoustic signal to detect SLNs. A total of 121 patients with breast cancer were enrolled, and 375 lymph nodes were excised using conventional SLNb. The PAF was used to measure the signal from the excised lymph nodes. We compared the SLN detection rates of each method (gamma probe, visual inspection, and PAF) and conducted a non-inferiority test. The PAF detected 87 % of SLNs, comparable to the gamma probe (85 %) and superior to visual inspection (73 %). Non-inferiority tests confirmed PAF's performance was not inferior to visual inspection (p < 0.001) or the gamma probe (p < 0.015). Using the dual-modal method (gamma probe + visual inspection) as the gold standard, PAF showed a sensitivity of 0.81 and specificity of 0.63. This study demonstrates that PAF, using only blue dye, offers a non-inferior alternative to the standard dual-modal SLN detection method with radioactive materials, opening new avenues for radiation-free SLNb in the future.