A Phase 2 interventional study of contrast agent perflutren lipid and Ultrasound Imaging in Breast Cancer, Kidney Neoplasms and Liver Neoplasms, sponsored by UNC Lineberger Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Phase 2, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
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Exclusion Criteria:
Participants without any disease diagnosis.
Drug: contrast agent perflutren lipid · Device: Ultrasound Imaging
Participants are going to be assessed breast cancer.
Drug: contrast agent perflutren lipid · Device: Ultrasound Imaging
Participants are going to be assessed kidney cancer.
Drug: contrast agent perflutren lipid · Device: Ultrasound Imaging
Participants are going to be assessed liver cancer.
Drug: contrast agent perflutren lipid · Device: Ultrasound Imaging
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.
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.
Also known as: Contrast Enhanced Super Resolution (CESR)
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)
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)
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)
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)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging
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.
Time frame: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging
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.
Time frame: Biopsy date (Up to 2 months)
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)
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)
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)
Plan to share: No
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