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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07225114
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • contrast agent perflutren lipid — DRUG
    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.
  • Ultrasound Imaging — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 4, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Arm 1: Healthy Volunteers
    Participants without any disease diagnosis.
  • Experimental: Arm 2: Breast Imaging Patients
    Participants are going to be assessed breast cancer.
  • Experimental: Arm 3: Kidney Imaging Patients
    Participants are going to be assessed kidney cancer.
  • Experimental: Arm 4: Liver Imaging Patients
    Participants are going to be assessed liver cancer.

Primary Outcome Measure

Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging [ Time Frame: Biopsy date (Up to 2 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of North CarolinaChapel HillNorth Carolina27599
Markeela Lipscomb
[email protected]
919-984-0000
Desma Jones
[email protected]
(919) - 966-3036
Yueh Z Lee, MD,PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The University of North Carolina· Chapel Hill, NC

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