Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults ≥18 years old
Patient had a diagnostic ultrasound study performed at University of North Carolina
Scheduled for a biopsy
Lesion visualized on ultrasound
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
contrast agent perflutren lipid
DrugAt 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
DeviceContrast 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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Arm 1: Healthy VolunteersExperimental treatment 2 interventions
Group B: Arm 2: Breast Imaging PatientsExperimental treatment 2 interventions
Group C: Arm 3: Kidney Imaging PatientsExperimental treatment 2 interventions
Group D: Arm 4: Liver Imaging PatientsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Biopsy date (Up to 2 months)2
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.
Time frame
Biopsy date (Up to 2 months)3
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.
Time frame
Biopsy date (Up to 2 months)4
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.
Time frame
Biopsy date (Up to 2 months)Secondary outcomes
1
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast
The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign breast lesions.
Time frame
Biopsy date (Up to 2 months)2
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney
The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign kidney lesions.
Time frame
Biopsy date (Up to 2 months)3
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver
The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign liver lesions.
Time frame
Biopsy date (Up to 2 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov