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

Phase 2RecruitingNCT07225114

UNC Lineberger Comprehensive Cancer Center40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer Kidney Neoplasms

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.