Recruiting
Phase 2

CESR Imaging

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT07225114

Conditions

Breast Cancer

Kidney Neoplasms

Liver Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

contrast agent perflutren lipid

Ultrasound Imaging

Study Details

Brief 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.

Conditions

Breast Cancer

Kidney Neoplasms

Liver Neoplasms

Study ID

NCT07225114

Start date

Nov 4, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Arm 1: Healthy Volunteers

Participants without any disease diagnosis.

experimental: Arm 2: Breast Imaging Patients

Participants are going to be assessed breast cancer.

experimental: Arm 3: Kidney Imaging Patients

Participants are going to be assessed kidney cancer.

experimental: Arm 4: Liver Imaging Patients

Participants are going to be assessed liver cancer.

Interventions

contrast agent perflutren lipid

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

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.

Primary outcome measure

  • Sensitivity 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 [ Time Frame: Biopsy date (Up to 2 months) ]
  • Sensitivity 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 [ Time Frame: Biopsy date (Up to 2 months) ]
  • Sensitivity 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 [ Time Frame: Biopsy date (Up to 2 months) ]

Central Contacts and Locations

Central contacts

Desma Jones

(919) 843-9463desma_jones@med.unc.edu

Markeela Lipscomb

(919) 843-3670markeela_lipscomb@med.unc.edu

Locations

The University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Markeela Lipscomb

919-984-0000markeela_lipscomb@med.unc.edu

Desma Jones

(919) - 966-3036desma_jones@med.unc.edu

Principal Investigator:

Yueh Z Lee, MD,PhD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • Definity®
  • perflutren lipid
  • healthy volunteers
  • ultrasound
  • cross-sectional imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-06-08.