Breast Cancer, Kidney Neoplasms, Liver Neoplasms
Conditions
Keywords
Definity®, perflutren lipid, healthy volunteers, ultrasound, cross-sectional imaging
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.
Interventions
DRUGcontrast 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.
DEVICEUltrasound 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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging | Biopsy date (Up to 2 months) | 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. |
| Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging | Biopsy date (Up to 2 months) | 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. |
| Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging | Biopsy date (Up to 2 months) | 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. |
| Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging | Biopsy date (Up to 2 months) | 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. |
| Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging | Biopsy date (Up to 2 months) | 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. |
| Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging | Biopsy date (Up to 2 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast | Biopsy date (Up to 2 months) | The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign breast lesions. |
| Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney | Biopsy date (Up to 2 months) | The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign kidney lesions. |
| Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver | Biopsy date (Up to 2 months) | The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign liver lesions. |
Countries
United States
Contacts
CONTACTDesma Jones
CONTACTMarkeela Lipscomb
PRINCIPAL_INVESTIGATORYueh Lee, MD
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed