Actively Recruiting
Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-06
40
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 69 18 years old
- Patient had a diagnostic ultrasound study performed at University of North Carolina
- Scheduled for a biopsy
- Lesion visualized on ultrasound
- Able to provide informed consent
- Negative urine pregnancy test in women of child-bearing potential
You will not qualify if you...
- Institutionalized subject (prisoner or nursing home patient)
- Critically ill or medically unstable with unpredictable critical course (e.g., COPD)
- Known hypersensitivity to sulfur hexafluoride or any component of perflutren lipid (Definity�AE)
- Active cardiac disease including severe congestive heart failure (class IV NYHA)
- Unstable angina
- Severe arrhythmia (ventricular tachycardia, flutter fibrillation, ventricular premature complexes near T-wave, multifocal complexes)
- Myocardial infarction within 14 days before Definity�AE administration
- Pulmonary hypertension
- Cardiac shunts
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
Research Team
D
Desma Jones
CONTACT
M
Markeela Lipscomb
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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