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RecruitingAccepts healthy volunteersPhase 2

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

UNC Lineberger Comprehensive Cancer Center · with National Cancer Institute (NCI) · NCT07225114

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
40
US sites recruiting
1
Study start
November 4, 2025
Record last updated
June 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: contrast agent perflutren lipid; Ultrasound Imaging

Conditions: Breast Cancer; Kidney Neoplasms; Liver Neoplasms

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • The University of North Carolina

    Chapel Hill, NC 27599

    Site contact: Markeela Lipscomb · 919-984-0000 · markeela_lipscomb@med.unc.edu

Study contacts (from the official record)

  • Desma Jones · (919) 843-9463 · desma_jones@med.unc.edu
  • Markeela Lipscomb · (919) 843-3670 · markeela_lipscomb@med.unc.edu
All healthy volunteers studies in North Carolina →
Translation of Acoustic Angiography: Contrast Enhanced Super… (NCT07225114) | Bored Studies