Contrast-Enhanced Super-Resolution (CESR) Ultrasound for Imaging Breast, Liver, and Kidney Lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, phase 2 interventional study will enroll 40 participants across four arms: 30 patients with known lesions (10 each in breast, liver, and kidney) and 10 healthy volunteers for imaging optimization. Participants will receive perflutren lipid contrast (Definity®) during ultrasound imaging with a new CESR protocol on an updated ultrasound system while operators adjust parameters like frame rate, power, depth, and translation rate. The primary goal is to measure the sensitivity and specificity of CESR for detecting and characterizing lesions, comparing image findings with pathology from scheduled biopsies. Results will inform whether CESR can be translated into clinical practice for improved lesion visualization.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Yueh Lee, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Desma Jones
• Email: desma_jones@med.unc.edu
• Phone: (919) 843-9463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.