NCT01490892

Quantitative Subharmonic Breast Imaging

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	3D HI and SHI of UCA	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)

Timeline

• Start date: 2011-11-01
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2011-12-13
• Last updated: 2025-05-06
• Results posted: 2020-01-13

Locations

2 sites across 1 country: United States