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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

  • Michael D. AlvaradoEmail author
  • Elizabeth A. Mittendorf
  • Mediget Teshome
  • Alastair M. Thompson
  • Richard J. Bold
  • Mark A. Gittleman
  • Peter D. Beitsch
  • Sarah L. Blair
  • Kaisa Kivilaid
  • Quentin J. Harmer
  • Kelly K. Hunt
Breast Oncology

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.

Notes

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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Copyright information

© Society of Surgical Oncology 2019

Authors and Affiliations

  • Michael D. Alvarado
    • 1
    Email author
  • Elizabeth A. Mittendorf
    • 2
  • Mediget Teshome
    • 2
  • Alastair M. Thompson
    • 2
  • Richard J. Bold
    • 3
  • Mark A. Gittleman
    • 4
  • Peter D. Beitsch
    • 5
  • Sarah L. Blair
    • 6
  • Kaisa Kivilaid
    • 7
  • Quentin J. Harmer
    • 8
  • Kelly K. Hunt
    • 2
  1. 1.Department of SurgeryUniversity of California San FranciscoSan FranciscoUSA
  2. 2.Department of Breast Surgical OncologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  3. 3.Division of Surgical Oncology, Department of SurgeryUC Davis Medical CenterSacramentoUSA
  4. 4.Breastcare SpecialistsAllentownUSA
  5. 5.Dallas Surgical GroupDallasUSA
  6. 6.Department of Surgery, Moores Cancer CenterUniversity of California San DiegoLa JollaUSA
  7. 7.Regulatory and Clinical Research Institute, Inc.MinneapolisUSA
  8. 8.Endomagnetics LimitedCambridgeUK

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