NCT07225114RecruitingPhase 2
Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Nov 2025
- Start date
- 4 Nov 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- NCT number
- NCT07225114
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 4 Nov 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
Other illness
- 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).
- Pulmonary hypertension
- Cardiac shunts
Other
- Institutionalized subject (prisoner or nursing home patient)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.