RecruitingPhase 2NCT07225114

Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of enhanced ultrasound imaging called Contrast-Enhanced Super Resolution (CESR) imaging that may show blood vessels inside tumors in much finer detail than standard ultrasound. It uses an approved ultrasound contrast agent (a tiny bubble substance) to improve image quality and potentially help doctors better evaluate tumors before biopsy. **You may be eligible if...** - You are 18 years or older - You had a standard ultrasound at the University of North Carolina that found a lesion (abnormal area) - You are scheduled for a biopsy of that lesion - You are able to provide informed consent - Women of childbearing age must have a negative pregnancy test **You may NOT be eligible if...** - You are a prisoner or nursing home resident - You are critically ill or medically unstable - You have a known allergy to sulfur hexafluoride or the contrast agent Definity - You have severe heart conditions including severe congestive heart failure, unstable angina, severe arrhythmia, recent heart attack within 14 days, or pulmonary hypertension - You have a cardiac shunt Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcontrast agent perflutren lipid

At the time of imaging, the contrast agent perflutren lipid will be administered, intravenous (IV). All patients will be visually monitored for signs or symptoms of a contrast administration reaction once the drug is administered for a 15-minute period.

DEVICEUltrasound Imaging

Contrast Enhanced Super Resolution (CESR) imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to CESR imaging for localization.


Locations(1)

The University of North Carolina

Chapel Hill, North Carolina, United States

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NCT07225114


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