Multicenter clinical trial on sentinel lymph node biopsy using superparamagnetic iron oxide nanoparticles and a novel handheld magnetic probe

Kanae Taruno, Tomoko Kurita, Akihiko Kuwahata, Keiko Yanagihara, Katsutoshi Enokido, Yoshihisa Katayose, Seigo Nakamura, Hiroyuki Takei, Masaki Sekino, Moriaki Kusakabe

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Sentinel lymph node biopsy is a standard staging procedure for early axillary lymph node-negative breast cancer. As an alternative to the currently used radioactive tracers for sentinel lymph node (SLN) detection during the surgical procedure, a number of studies have shown promising results using superparamagnetic iron oxide (SPIO) nanoparticles. Here, we developed a new handheld, cordless, and lightweight magnetic probe for SPIO detection. Methods: Resovist (SPIO nanoparticles) were detected by the newly developed handheld probe, and the SLN detection rate was compared to that of the standard radioisotope (RI) method using radioactive colloids (99mTc) and a blue dye (indigo carmine). This was a multicenter prospective clinical trial that included 220 patients with breast cancer scheduled for sentinel node biopsy after a clinical diagnosis of negative axillary lymph node from three facilities in Japan. Results: Of the 210 patients analyzed, SLN was detected in 94.8% (199/210 cases, 90% confidence interval [CI]) with our magnetic method and in 98.1% (206/210 cases, 90% CI) with the RI method. The magnetic method exceeded the threshold identification rate of 90%. Conclusion: This was the first clinical study to use a novel handheld magnetometer to detect SLN, which we demonstrate to be not inferior to the RI method.

Original languageEnglish
Pages (from-to)1391-1396
Number of pages6
JournalJournal of Surgical Oncology
Volume120
Issue number8
DOIs
Publication statusPublished - 2019 Dec 1
Externally publishedYes

Keywords

  • breast cancer
  • magnetic probe
  • sentinel lymph node biopsy
  • superparamagnetic iron oxide

ASJC Scopus subject areas

  • Surgery
  • Oncology

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