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SentimagIC: A Non-inferiority Trial Comparing Superparamagnetic Iron Oxide Versus Technetium-99m and Blue Dye in the Detection of Axillary Sentinel Nodes in Patients with Early-Stage Breast Cancer

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

A Correction to this article was published on 08 June 2020

This article has been updated

Abstract

Background

Sentinel lymph node biopsy (SLNB) is a highly accurate method for staging the axilla in early breast cancer. Superparamagnetic iron oxide mapping agents have been explored to overcome the disadvantages of the standard SLNB technique, which uses a radioisotope tracer with or without blue dye. One such agent, Sienna+, was shown to be non-inferior to the standard technique for SLNB in a number of studies. The SentimagIC trial was designed to establish the non-inferiority of a new formulation of this magnetic tracer, Magtrace (formerly SiennaXP).

Methods

Patients with clinically node-negative early-stage breast cancer were recruited from six centers in the US. Patients received radioisotope and isosulfan blue dye injections, followed by an intraoperative injection of magnetic tracer, prior to SLNB. The sentinel node identification rate was compared between the magnetic and standard techniques to evaluate non-inferiority and concordance.

Results

Data were collected for 146 procedures in 146 patients. The per patient detection rate was 99.3% (145/146) when using the magnetic tracer and 98.6% (144/146) when using the standard technique, while the nodal detection rate was 94.3% (348/369 nodes) when using the magnetic tracer and 93.5% (345/369) when using the standard technique (difference 0.8%, 95% binomial confidence interval lower bound − 2.1%). Of the 22 patients with positive sentinel lymph nodes (SLNs), 21 (95.4%) were detected by both the magnetic tracer and the standard technique. All malignant nodes detected by standard technique were also identified by the magnetic technique.

Conclusion

The magnetic technique is non-inferior to the standard technique of radioisotope and blue dye for axillary SLN detection in early-stage breast cancer. The magnetic technique is therefore a viable alternative.

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Change history

  • 08 June 2020

    In the original article the authors��� disclosures were incomplete.

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Acknowledgment

This clinical study was sponsored by Endomagnetics Inc. Clarice Scofield (Regulatory and Clinical Research Institute Inc.) provided clinical trial management, and Patrick Wang (University of California San Francisco) provided administrative support.

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Authors and Affiliations

  1. Department of Surgery, University of California San Francisco, San Francisco, CA, USA

    Michael D. Alvarado MD

  2. Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

    Elizabeth A. Mittendorf MD, Mediget Teshome MD, Alastair M. Thompson MD & Kelly K. Hunt MD

  3. Division of Surgical Oncology, Department of Surgery, UC Davis Medical Center, Sacramento, CA, USA

    Richard J. Bold MD

  4. Breastcare Specialists, Allentown, PA, USA

    Mark A. Gittleman MD

  5. Dallas Surgical Group, Dallas, TX, USA

    Peter D. Beitsch MD

  6. Department of Surgery, Moores Cancer Center, University of California San Diego, La Jolla, CA, USA

    Sarah L. Blair MD

  7. Regulatory and Clinical Research Institute, Inc., Minneapolis, MN, USA

    Kaisa Kivilaid MS

  8. Endomagnetics Limited, Cambridge, UK

    Quentin J. Harmer PhD

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  1. Michael D. Alvarado MD
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  2. Elizabeth A. Mittendorf MD
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Correspondence to Michael D. Alvarado MD.

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Alvarado, M.D., Mittendorf, E.A., Teshome, M. et al. SentimagIC: A Non-inferiority Trial Comparing Superparamagnetic Iron Oxide Versus Technetium-99m and Blue Dye in the Detection of Axillary Sentinel Nodes in Patients with Early-Stage Breast Cancer. Ann Surg Oncol 26, 3510–3516 (2019). https://doi.org/10.1245/s10434-019-07577-4

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