99mTc-labeled sodium phytate and stannous chloride injection accurately detects sentinel lymph node in axillary of early stage breast cancer: a randomized, controlled study

Suisheng Yang, Weiyu Bao, Xiaorong Bai, Chen Gao, Binming Zhang, Zhuanji Jiang, Suisheng Yang, Weiyu Bao, Xiaorong Bai, Chen Gao, Binming Zhang, Zhuanji Jiang

Abstract

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.

Keywords: 99mTc; breast cancer; detection rate; sentinel lymph node biopsy; sodium phytate; stannous chloride.

Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
The lymphoscintigraphies in 99mTc-PHY and 99mTc-SC groups. Notes: (A) The lymphoscintigraphy after RA injection, 1 hour before surgery in 99mTc-PHY group. (B) The lymphoscintigraphy after RA injection, 1 hour before surgery in 99mTc-SC group. Abbreviations:99mTc-PHY, 99mTc-labeled sodium phytate and stannous chloride; 99mTc-SC, 99mTc-labeled sulfur colloid; RA, radioactive agent; SLN, sentinel lymph node.
Figure 2
Figure 2
An identified SLN and its radiation count rate. Notes: (A) An identified SLN. (B) The radiation count rate of the identified SLN. Abbreviation: SLN, sentinel lymph node.
Figure 3
Figure 3
Study flow. Note: 208 patients with breast cancer were screened for eligibility, and 62 were excluded, remaining 146 patients were randomly allocated in 1:1 ratio to 99mTc-PHY and 99mTc-SC groups. Abbreviations:99mTc-PHY, 99mTc-labeled sodium phytate and stannous chloride; 99mTc-SC, 99mTc-labeled sulfur colloid; SLNB, sentinel lymph node biopsy; ALND, axillary lymph node dissection.

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