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Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
North Carolina
The University of North Carolina
RECRUITING
Chapel Hill
Contact Information
Primary
Desma Jones
desma_jones@med.unc.edu
(919) 843-9463
Backup
Markeela Lipscomb
markeela_lipscomb@med.unc.edu
(919) 843-3670
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Leads: UNC Lineberger Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov