This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for
a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The
primary objective of this trial is:
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).
The secondary aim of this trial is:
To compare quantitative (bifurcations & vessel length) and semi-quantitative (blood pool &
parametric imaging) measures of the vascular morphology of breast lesions determined by
pathology and by SHI.
Phase:
Phase 4
Details
Lead Sponsor:
Thomas Jefferson University
Collaborators:
Lantheus Medical Imaging National Cancer Institute (NCI) University of California, San Diego