Contrast-Enhanced Super-Resolution (CESR) Ultrasound for Imaging Breast, Liver, and Kidney Lesions
Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
The team will try a new contrast-enhanced super-resolution ultrasound (CESR) to see if it images known lesions in the breast, liver, or kidney more clearly in adults scheduled for biopsy and in healthy volunteers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07225114 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a lesion in the breast, liver, or kidney visible on ultrasound who are scheduled for biopsy and can provide informed consent, plus healthy adults for the optimization arm, are eligible.
Not a fit: People with known hypersensitivity to perflutren lipid (Definity®), active severe cardiac disease, pregnant women, institutionalized or critically unstable patients, or those whose lesions are not visible on ultrasound are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, CESR could provide clearer, higher-resolution ultrasound images of small or complex lesions, potentially improving biopsy targeting and treatment planning.
How similar studies have performed: Contrast-enhanced ultrasound methods and early super-resolution imaging approaches have shown promise in prior research, but translating CESR to human breast, liver, and kidney imaging is relatively new and not yet widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.