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NCT Number: NCT07225114

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

contrast agent perflutren lipid

Drug

At the time of imaging, the contrast agent perflutren lipid will be administered, intravenous (IV). All patients will be visually monitored for signs or symptoms of a contrast administration reaction once the drug is administered for a 15-minute period.

Ultrasound Imaging

Device

Contrast Enhanced Super Resolution (CESR) imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to CESR imaging for localization.

Other names: Contrast Enhanced Super Resolution (CESR)

Primary outcomes

  1. Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging

    Time frame: Biopsy date (Up to 2 months)

    Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions.

    Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.

  2. Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging

    Time frame: Biopsy date (Up to 2 months)

    Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions.

    Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.

  3. Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging

    Time frame: Biopsy date (Up to 2 months)

    Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions.

    Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.

  4. Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging

    Time frame: Biopsy date (Up to 2 months)

    Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions.

    Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.

  5. Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging

    Time frame: Biopsy date (Up to 2 months)

    Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions.

    Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.

  6. Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging

    Time frame: Biopsy date (Up to 2 months)

    Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions.

    Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.

Secondary outcomes

  1. Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast

    Time frame: Biopsy date (Up to 2 months)

    The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign breast lesions.

  2. Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney

    Time frame: Biopsy date (Up to 2 months)

    The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign kidney lesions.

  3. Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver

    Time frame: Biopsy date (Up to 2 months)

    The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign liver lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Desma Jones

CONTACT

[email protected]

(919) 843-9463

Markeela Lipscomb

CONTACT

[email protected]

(919) 843-3670

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 5, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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