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Title: 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

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 boundmore » − 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.« less

Authors:
; ;  [1];  [2];  [3];  [4];  [5];  [6];  [7];  [1]
  1. The University of Texas MD Anderson Cancer Center, Department of Breast Surgical Oncology (United States)
  2. UC Davis Medical Center, Division of Surgical Oncology, Department of Surgery (United States)
  3. Breastcare Specialists (United States)
  4. Dallas Surgical Group (United States)
  5. University of California San Diego, Department of Surgery, Moores Cancer Center (United States)
  6. Regulatory and Clinical Research Institute, Inc. (United States)
  7. Endomagnetics Limited (United Kingdom)
Publication Date:
OSTI Identifier:
22927569
Resource Type:
Journal Article
Journal Name:
Annals of Surgical Oncology (Online)
Additional Journal Information:
Journal Volume: 26; Journal Issue: 11; Other Information: Copyright (c) 2019 Society of Surgical Oncology; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 1534-4681
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BIOPSY; IRON OXIDES; LYMPH NODES; MAMMARY GLANDS; NEOPLASMS; PATIENTS; SUPERPARAMAGNETISM

Citation Formats

Alvarado, Michael D., E-mail: michael.alvarado@ucsf.edu, Mittendorf, Elizabeth A., Teshome, Mediget, Thompson, Alastair M., Bold, Richard J., Gittleman, Mark A., Beitsch, Peter D., Blair, Sarah L., Kivilaid, Kaisa, Harmer, Quentin J., and Hunt, Kelly K.. 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. United States: N. p., 2019. Web. doi:10.1245/S10434-019-07577-4.
Alvarado, Michael D., E-mail: michael.alvarado@ucsf.edu, Mittendorf, Elizabeth A., Teshome, Mediget, Thompson, Alastair M., Bold, Richard J., Gittleman, Mark A., Beitsch, Peter D., Blair, Sarah L., Kivilaid, Kaisa, Harmer, Quentin J., & Hunt, Kelly K.. 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. United States. https://doi.org/10.1245/S10434-019-07577-4
Alvarado, Michael D., E-mail: michael.alvarado@ucsf.edu, Mittendorf, Elizabeth A., Teshome, Mediget, Thompson, Alastair M., Bold, Richard J., Gittleman, Mark A., Beitsch, Peter D., Blair, Sarah L., Kivilaid, Kaisa, Harmer, Quentin J., and Hunt, Kelly K.. 2019. "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". United States. https://doi.org/10.1245/S10434-019-07577-4.
@article{osti_22927569,
title = {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},
author = {Alvarado, Michael D., E-mail: michael.alvarado@ucsf.edu and Mittendorf, Elizabeth A. and Teshome, Mediget and Thompson, Alastair M. and Bold, Richard J. and Gittleman, Mark A. and Beitsch, Peter D. and Blair, Sarah L. and Kivilaid, Kaisa and Harmer, Quentin J. and Hunt, Kelly K.},
abstractNote = {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.},
doi = {10.1245/S10434-019-07577-4},
url = {https://www.osti.gov/biblio/22927569}, journal = {Annals of Surgical Oncology (Online)},
issn = {1534-4681},
number = 11,
volume = 26,
place = {United States},
year = {2019},
month = {10}
}