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

Qualifiers

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

Treatments tested in this trial

  • contrast agent perflutren lipid
  • Ultrasound Imaging

Treatment groups

40 Participants
are divided into 4 treatment groups

Sponsors and collaborators

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator