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

NCT07225114 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 2 other identifiers: LCCC2451R01CA220681
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

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

  Biopsy date (Up to 2 months)

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

  Biopsy date (Up to 2 months)

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

  Biopsy date (Up to 2 months)

Study Arms (4)

Arm 1: Healthy Volunteers

EXPERIMENTAL

Participants without any disease diagnosis.

Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging

Arm 2: Breast Imaging Patients

EXPERIMENTAL

Participants are going to be assessed breast cancer.

Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging

Arm 3: Kidney Imaging Patients

EXPERIMENTAL

Participants are going to be assessed kidney cancer.

Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging

Arm 4: Liver Imaging Patients

EXPERIMENTAL

Participants are going to be assessed liver cancer.

Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging

Interventions

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.

Arm 1: Healthy Volunteers; Arm 2: Breast Imaging Patients; Arm 3: Kidney Imaging Patients; Arm 4: Liver Imaging Patients

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.

Also known as: Contrast Enhanced Super Resolution (CESR)

Arm 1: Healthy Volunteers; Arm 2: Breast Imaging Patients; Arm 3: Kidney Imaging Patients; Arm 4: Liver Imaging Patients

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

The University of North Carolina

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Kidney Neoplasms; Liver Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yueh Lee, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desma Jones

CONTACT

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

Markeela Lipscomb

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)