At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Quantitative Subharmonic Breast Imaging
In Brief
A Phase 4 clinical trial evaluating 3D HI and SHI of UCA for Breast Cancer. Completed, enrolled 219 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)