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

NCT ID: NCT07225114

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-04
• Study Completion Date: 2028-12-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1: Healthy Volunteers

Participants without any disease diagnosis.

Group Type: EXPERIMENTAL

contrast agent perflutren lipid

Intervention Type: 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

Intervention Type: 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.

Arm 2: Breast Imaging Patients

Participants are going to be assessed breast cancer.

Group Type: EXPERIMENTAL

contrast agent perflutren lipid

Intervention Type: 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

Intervention Type: 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.

Arm 3: Kidney Imaging Patients

Participants are going to be assessed kidney cancer.

Group Type: EXPERIMENTAL

contrast agent perflutren lipid

Intervention Type: 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

Intervention Type: 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.

Arm 4: Liver Imaging Patients

Participants are going to be assessed liver cancer.

Group Type: EXPERIMENTAL

contrast agent perflutren lipid

Intervention Type: 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

Intervention Type: 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.

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

Contrast Enhanced Super Resolution (CESR)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yueh Lee, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Lineberger Comprehensive Cancer Center

Locations

The University of North Carolina

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Desma Jones

Role: CONTACT

desma_jones@med.unc.edu

(919) 843-9463

Markeela Lipscomb

Role: CONTACT

markeela_lipscomb@med.unc.edu

(919) 843-3670

Facility Contacts

Markeela Lipscomb

Role: primary

markeela_lipscomb@med.unc.edu

919-984-0000

Desma Jones

Role: backup

desma_jones@med.unc.edu

(919) - 966-3036

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

R01CA220681

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCCC2451

Identifier Type: -

Identifier Source: org_study_id