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

Academic-Industrial Partnership for 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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Neoplasms; Breast Cancer; Liver Neoplasms
• Intervention / Treatment: Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Desma Jones; Phone Number: (919) 843-9463; Email: desma_jones@med.unc.edu
• Study Contact Backup: Name: Markeela Lipscomb; Phone Number: (919) 843-3670; Email: markeela_lipscomb@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • The University of North Carolina
      • Contact: Markeela Lipscomb; Phone Number: 919-984-0000; Email: markeela_lipscomb@med.unc.edu
      • Contact: Desma Jones; Phone Number: (919) - 966-3036; Email: desma_jones@med.unc.edu
      • Principal Investigator: Yueh Z Lee, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Healthy Volunteers; Participants without any disease diagnosis.	Drug: 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.; Device: 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.; Other Names: Contrast Enhanced Super Resolution (CESR)
Experimental: Arm 2: Breast Imaging Patients; Participants are going to be assessed breast cancer.	Drug: 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.; Device: 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.; Other Names: Contrast Enhanced Super Resolution (CESR)
Experimental: Arm 3: Kidney Imaging Patients; Participants are going to be assessed kidney cancer.	Drug: 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.; Device: 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.; Other Names: Contrast Enhanced Super Resolution (CESR)
Experimental: Arm 4: Liver Imaging Patients; Participants are going to be assessed liver cancer.	Drug: 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.; Device: 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.; Other Names: Contrast Enhanced Super Resolution (CESR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging	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.	Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging	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.	Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging	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.	Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging	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.	Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging	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.	Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging	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.	Biopsy date (Up to 2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast	The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign breast lesions.	Biopsy date (Up to 2 months)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney	The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign kidney lesions.	Biopsy date (Up to 2 months)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver	The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign liver lesions.	Biopsy date (Up to 2 months)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Yueh Lee, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Estimated): November 5, 2025

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; healthy volunteers; Definity®; perflutren lipid; cross-sectional imaging
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Skin Diseases; Breast Diseases; Urologic Neoplasms; Skin and Connective Tissue Diseases; Breast Neoplasms; Liver Neoplasms; Kidney Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: LCCC2451; R01CA220681 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No