Recruiting

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

ClinicalTrials.gov IDNCT07225114

PhasePHASE2

Enrollment40

SponsorUNC Lineberger Comprehensive Cancer Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Kidney Neoplasms, Liver Neoplasms

About this study

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.

Interventions

Drug: contrast 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.
Device: Ultrasound 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.

Primary outcomes

Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging (Biopsy date (Up to 2 months))
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging (Biopsy date (Up to 2 months))
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging (Biopsy date (Up to 2 months))
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging (Biopsy date (Up to 2 months))
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging (Biopsy date (Up to 2 months))
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging (Biopsy date (Up to 2 months))

Eligibility information

Inclusion Criteria: * Adults ≥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 Exclusion Criteria: * 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 * Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association) * Unstable angina. * Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes). * Myocardial infarction within 14 days prior to the date of proposed Definity® administration. * Pulmonary hypertension * Cardiac shunts

Study locations

The University of North Carolina, Chapel Hill, North Carolina 27599 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.