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

Last updated: January 2, 2026
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Breast Cancer

Digestive System Neoplasms

Treatment

contrast agent perflutren lipid

Ultrasound Imaging

Clinical Study ID

NCT07225114
LCCC2451
R01CA220681
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Institutionalized subject (prisoner or nursing home patient)

  • Critically ill or medically unstable and whose critical course during theobservation period would be unpredictable (e.g., chronic obstructive pulmonarydisease (COPD)

  • Known hypersensitivity to sulfur hexafluoride or to any component of perflutrenlipid (Definity®)

  • Active cardiac disease including any of the following

  • Severe congestive heart failure (class IV in accordance with the classification ofthe New York Heart Association)

  • Unstable angina.

  • Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricularpremature 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 Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: contrast agent perflutren lipid
Phase: 2
Study Start date:
November 04, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • The University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

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