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Annals of Surgical Oncology

, Volume 25, Issue 12, pp 3740–3746 | Cite as

Doppler Ultrasound-Visible SignalMark Microspheres are Better Identified than HydroMARK® Clips in a Simulated Intraoperative Setting in Breast and Lung Tissue

  • Rachel K. Voss
  • Erin P. Ward
  • Haydee Ojeda-Fournier
  • Sarah L. Blair
Translational Research and Biomarkers
  • 49 Downloads

Abstract

Background

Preoperative breast and lung markers have significant drawbacks, including migration, patient discomfort, and scheduling difficulties. SignalMark is a novel localizer device with a unique signal on Doppler ultrasound.

Objective

We aimed to evaluate intraoperative identification of SignalMark microspheres compared with HydroMARK® clips. We also assessed the safety and efficacy of SignalMark in the lung.

Methods

Twelve breasts of lactating pigs were injected with SignalMark or HydroMARK® by a breast radiologist, and subsequently identified using a standard ultrasound machine by three surgeons blinded to marker location. Time to identification of each marker was recorded, with a maximum allotted time of 300 s. To further demonstrate efficacy in lung parenchyma, a second cohort of pigs underwent lung injections.

Results

A total of eight SignalMark markers and four HydroMARK® clips were placed in pig breasts. Overall, the surgeons correctly identified SignalMark 95.8% of the time (n = 23/24) and HydroMARK® clips 41.7% of the time (n = 5/12) within 300 s (p < 0.001). The mean time to identification was significantly faster for SignalMark, at 80.8 ± 20.1 s, than for HydroMARK®, at 209.4 ± 35.2 s (p < 0.002). For the lung injections, all 10 SignalMark markers were visible on Doppler ultrasound at the time of placement, and at the 7- and 21-day time points.

Conclusions

Surgeons identified SignalMark in significantly less time than HydroMARK® clips in a simulated intraoperative setting, and SignalMark was easily viewed in the lung. These results suggest that SignalMark is a feasible option for efficient intraoperative localization of non-palpable breast and lung tumors using ultrasound guidance.

Notes

Disclosures

This study was funded by Viewpoint Medical. S.L.B. has a family member with an equity interest in Nanocyte Medical, Inc., a company that may potentially benefit from the research results. H.O.F. is a consultant. The terms of this arrangement have been reviewed and approved by the University of California, San Diego, in accordance with its conflict of interest policies.

Supplementary material

10434_2018_6707_MOESM1_ESM.tif (209 kb)
Dimensions of the (a) lung marker and (b) breast marker used in the study (TIFF 209 kb)
10434_2018_6707_MOESM2_ESM.jpg (43 kb)
SignalMark breast marker and 16-guage injector device (JPEG 42 kb)

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Copyright information

© Society of Surgical Oncology 2018

Authors and Affiliations

  • Rachel K. Voss
    • 1
  • Erin P. Ward
    • 1
  • Haydee Ojeda-Fournier
    • 2
  • Sarah L. Blair
    • 1
  1. 1.Department of SurgeryUniversity of California San DiegoSan DiegoUSA
  2. 2.Department of RadiologyUC San Diego HealthSan DiegoUSA

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