Quantitative Subharmonic Breast Imaging
This is an open-label, non-randomized trial that will be conducted at two clinical sites
(the Breast Imaging Centers at Thomas Jefferson University (TJU) Hospital and University of
California, San Diego (UCSD) Hospital). All 450 subjects will receive at most two IV bolus
injections of Definity (Lantheus Medical Imaging, Billerica, MA), will undergo an unenhanced
(baseline) and Definity contrast-enhanced US imaging study for evaluation of a breast mass
or breast abnormality without mass, and will be scheduled to undergo a clinically indicated
biopsy of the breast lesion under investigation.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Breast lesion characterization with 3D SHI
To evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI) can improve the characterization of benign and malignant breast masses (independently or in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale ultrasound (US) or power Doppler imaging (PDI).
Flemming Forsberg, phD
Thomas Jefferson University
United States: Food and Drug Administration
|University of California, San Diego||La Jolla, California 92037-1709|
|Thomas Jefferson University, Dept of Radiology||Philadelphia, Pennsylvania 19107|