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

UNC Lineberger Comprehensive Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer; Liver Neoplasms; Kidney Neoplasms

Treatments: Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07225114

LCCC2451

R01CA220681 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Arm 1: Healthy Volunteers

Experimental group

Description:

Participants without any disease diagnosis.

Treatment:

Device: Ultrasound Imaging

Drug: contrast agent perflutren lipid

Arm 2: Breast Imaging Patients

Experimental group

Description:

Participants are going to be assessed breast cancer.

Treatment:

Device: Ultrasound Imaging

Drug: contrast agent perflutren lipid

Arm 3: Kidney Imaging Patients

Experimental group

Description:

Participants are going to be assessed kidney cancer.

Treatment:

Device: Ultrasound Imaging

Drug: contrast agent perflutren lipid

Arm 4: Liver Imaging Patients

Experimental group

Description:

Participants are going to be assessed liver cancer.

Treatment:

Device: Ultrasound Imaging

Drug: contrast agent perflutren lipid