99m 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 99m Tc-labeled sodium phytate and stannous chloride (99m Tc-PHY) injection versus 99m Tc-labeled sulfur colloid (99m 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 99m Tc-PHY or 99m 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 99m Tc-PHY group was higher compared with that of 99m Tc-SC group ( p =0.023), but no difference in the detection rate by dye alone ( p =0.190) or by RAs alone ( p =0.615) was found between the two groups, and the number of identified SLNs ( p =0.100), number of identified SLNs by dye alone ( p =0.161), and number of identified SLNs by RA alone ( p =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 99m Tc-PHY and 99m Tc-SC groups (sensitivity: p =0.645; specificity: p =0.511; false-negative rate: p =0.645; false-positive rate: p =0.511; accuracy rate: p =0.464).

Conclusion: Our study revealed that 99m Tc-PHY was qualified to be a convincing radiopharmaceutical in SLNB.