Tc-labeled sodium phytate and stannous chloride injection accurately detects sentinel lymph node in axillary of early stage breast cancer: a randomized, controlled study.

Aim: The aim of this study was to assess the sentinel lymph node (SLN) detection rate and accuracy of Tc-labeled sodium phytate and stannous chloride (Tc-PHY) injection versus Tc-labeled sulfur colloid (Tc-SC) injection in sentinel lymph node biopsy (SLNB) in patients with early stage breast cancer.

Methods: A total of 146 consecutive female patients with early stage breast cancer were recruited in this open-labeled, randomized, controlled study. SLNB was conducted on all patients, and Tc-PHY or Tc-SC was used as the radioactive agent (RA). Axillary lymph node dissections were performed in all patients post SLN dissections.

Results: The detection rate of Tc-PHY group was higher compared with that of Tc-SC group (=0.023), but no difference in the detection rate by dye alone (=0.190) or by RAs alone (=0.615) was found between the two groups, and the number of identified SLNs (=0.100), number of identified SLNs by dye alone (=0.161), and number of identified SLNs by RA alone (=0.242) were similar between the two groups. In addition, the sensitivity, specificity, false-negative rate, false-positive rate, and accuracy rate of SLNB showed no difference between Tc-PHY and Tc-SC groups (sensitivity: =0.645; specificity: =0.511; false-negative rate: =0.645; false-positive rate: =0.511; accuracy rate: =0.464).

Conclusion: Our study revealed that Tc-PHY was qualified to be a convincing radiopharmaceutical in SLNB.