About this trial
This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Recruitment will be conducted such that ten patients are included from each anatomic region.
The fourth arm will consist of 10 healthy volunteers who will be imaged to allow optimization of imaging parameters. Optimization is is required again due to the use of a different ultrasound system employing a new imaging technique. Parameters such as frame rate, power, depth of imaging, and linear translation rate will be adjusted during this process.
The primary objectives of the study are to assess the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in evaluating known lesions in the breast, liver, and kidney. These results will be compared with pathological findings. The secondary objectives are to compare the sensitivity and specificity of CESR imaging with those of traditional B-mode ultrasound in differentiating malignant from benign lesions in these same organs.
Eligibility criteria
Qualifiers
Adults ≥18 years old
Patient had a diagnostic ultrasound study performed at University of North Carolina
Scheduled for a biopsy
Lesion visualized on ultrasound
Disqualifiers
Institutionalized subject (prisoner or nursing home patient)
Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
Active cardiac disease including any of the following
Trial design
Treatments tested in this trial
- contrast agent perflutren lipid
- Ultrasound Imaging
Treatment groups
Sponsors and collaborators
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator