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 99mTc-labeled sodium phytate and stannous chloride (99mTc-PHY) injection versus 99mTc-labeled sulfur colloid (99mTc-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 99mTc-PHY or 99mTc-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 99mTc-PHY group was higher compared with that of 99mTc-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 99mTc-PHY and 99mTc-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 99mTc-PHY was qualified to be a convincing radiopharmaceutical in SLNB.