Quantitative Subharmonic Breast Imaging

Summary

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.

Timeline

Start

2011-11

Primary completion

2019-04-05

Completion

2019-04-05

Publications

• Background Forsberg F, Piccoli CW, Merton DA, Palazzo JJ, Hall AL. Breast lesions: imaging with contrast-enhanced subharmonic US--initial experience. Radiology. 2007 Sep;244(3):718-26. doi: 10.1148/radiol.2443061588. Epub 2007 Aug 9.

Drugs

Indications