TY - JOUR
T1 - 3D Harmonic and Subharmonic Imaging for Characterizing Breast Lesions
T2 - A Multi-Center Clinical Trial
AU - Forsberg, Flemming
AU - Piccoli, Catherine W.
AU - Sridharan, Anush
AU - Wilkes, Annina
AU - Sevrukov, Alexander
AU - Ojeda-Fournier, Haydee
AU - Mattrey, Robert F.
AU - Machado, Priscilla
AU - Stanczak, Maria
AU - Merton, Daniel A.
AU - Wallace, Kirk
AU - Eisenbrey, John R.
N1 - Funding Information:
FF: Equipment, contrast agent, and grants support from GE Healthcare. Equipment and grant support from Canon Medical Systems America. Equipment and grant support from the Butterfly Network. Drug support and speaker honorarium from Lantheus Medical Imaging. Equipment support from Siemens Healthineers. Drug support from Bracco. Consultant for Samumed and Exact Therapeutics. KW: Employee of GE. JRE: Equipment, contrast agent, and grants support from GE Healthcare. Drug support and speaker honorarium from Lantheus Medical Imaging. Equipment support from Siemens Healthineers. Royalties from Elsevier. Others have reported no disclosures.
Funding Information:
We gratefully acknowledge the efforts of the many research coordinators who helped recruit subjects for this trial. This work was supported by National Institutes of Health Grant R01 CA140338, U.S. Army Medical Research Material Command Grant W81XWH‐11‐1‐0630, and by Lantheus Medical Imaging, N. Billerica, MA, which supplied the ultrasound contrast agent Definity.
Publisher Copyright:
© 2021 American Institute of Ultrasound in Medicine.
PY - 2022/7
Y1 - 2022/7
N2 - Objective: Breast cancer is the most frequent type of cancer among women. This multi-center study assessed the ability of 3D contrast-enhanced ultrasound to characterize suspicious breast lesions using clinical assessments and quantitative parameters. Methods: Women with suspicious breast lesions scheduled for biopsy were enrolled in this prospective, study. Following 2D grayscale ultrasound and power Doppler imaging (PDI), a contrast agent (Definity; Lantheus) was administrated. Contrast-enhanced 3D harmonic imaging (HI; transmitting/receiving at 5.0/10.0 MHz), as well as 3D subharmonic imaging (SHI; transmitting/receiving at 5.8/2.9 MHz), were performed using a modified Logiq 9 scanner (GE Healthcare). Five radiologists independently scored the imaging modes (including standard-of-care imaging) using a 7-point BIRADS scale as well as lesion vascularity and diagnostic confidence. Parametric volumes were constructed from time-intensity curves for vascular heterogeneity, perfusion, and area under the curve. Diagnostic accuracy was determined relative to pathology using receiver operating characteristic (ROC) and reverse, step-wise logistical regression analyses. The κ-statistic was calculated for inter-reader agreement. Results: Data were successfully acquired in 219 cases and biopsies indicated 164 (75%) benign and 55 (25%) malignant lesions. SHI depicted more anastomoses and vascularity than HI (P <.021), but there were no differences by pathology (P >.27). Ultrasound achieved accuracies of 82 to 85%, which was significantly better than standard-of-care imaging (72%; P <.03). SHI increased diagnostic confidence by 3 to 6% (P <.05), but inter-reader agreements were medium to low (κ < 0.52). The best regression model achieved 97% accuracy by combining clinical reads and parametric SHI. Conclusions: Combining quantitative 3D SHI parameters and clinical assessments improves the characterization of suspicious breast lesions.
AB - Objective: Breast cancer is the most frequent type of cancer among women. This multi-center study assessed the ability of 3D contrast-enhanced ultrasound to characterize suspicious breast lesions using clinical assessments and quantitative parameters. Methods: Women with suspicious breast lesions scheduled for biopsy were enrolled in this prospective, study. Following 2D grayscale ultrasound and power Doppler imaging (PDI), a contrast agent (Definity; Lantheus) was administrated. Contrast-enhanced 3D harmonic imaging (HI; transmitting/receiving at 5.0/10.0 MHz), as well as 3D subharmonic imaging (SHI; transmitting/receiving at 5.8/2.9 MHz), were performed using a modified Logiq 9 scanner (GE Healthcare). Five radiologists independently scored the imaging modes (including standard-of-care imaging) using a 7-point BIRADS scale as well as lesion vascularity and diagnostic confidence. Parametric volumes were constructed from time-intensity curves for vascular heterogeneity, perfusion, and area under the curve. Diagnostic accuracy was determined relative to pathology using receiver operating characteristic (ROC) and reverse, step-wise logistical regression analyses. The κ-statistic was calculated for inter-reader agreement. Results: Data were successfully acquired in 219 cases and biopsies indicated 164 (75%) benign and 55 (25%) malignant lesions. SHI depicted more anastomoses and vascularity than HI (P <.021), but there were no differences by pathology (P >.27). Ultrasound achieved accuracies of 82 to 85%, which was significantly better than standard-of-care imaging (72%; P <.03). SHI increased diagnostic confidence by 3 to 6% (P <.05), but inter-reader agreements were medium to low (κ < 0.52). The best regression model achieved 97% accuracy by combining clinical reads and parametric SHI. Conclusions: Combining quantitative 3D SHI parameters and clinical assessments improves the characterization of suspicious breast lesions.
KW - 3D ultrasound imaging
KW - breast cancer
KW - contrast-enhanced ultrasound
KW - harmonic imaging
KW - subharmonic imaging
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U2 - 10.1002/jum.15848
DO - 10.1002/jum.15848
M3 - Article
C2 - 34694019
AN - SCOPUS:85117843661
SN - 0278-4297
VL - 41
SP - 1667
EP - 1675
JO - Journal of Ultrasound in Medicine
JF - Journal of Ultrasound in Medicine
IS - 7
ER -