NCT07225114

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

Recruiting now Phase 2 Last updated 4 June 2026

What this trial tests

Phase 2 trial testing contrast agent perflutren lipid in Breast Cancer in 40 participants. Currently enrolling.

Timeline

4 November 2025

Primary endpoint
1 December 2028

1 December 2028

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	40
Start date	4 November 2025
Primary completion	1 December 2028
Estimated completion	1 December 2028
Sites	1 location across United States

Drugs / interventions tested

• contrast agent perflutren lipid — full drug profile →
• Ultrasound Imaging

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Kidney Neoplasms — all drugs for Kidney Neoplasms →
• Liver Neoplasms — all drugs for Liver Neoplasms →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Kidney Neoplasms. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging
  Time frame: Biopsy date (Up to 2 months)
  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.
• Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging
  Time frame: Biopsy date (Up to 2 months)
  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.
• Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
  Time frame: Biopsy date (Up to 2 months)
  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.
• Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
  Time frame: Biopsy date (Up to 2 months)
  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.
• Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging
  Time frame: Biopsy date (Up to 2 months)
  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.
• Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging
  Time frame: Biopsy date (Up to 2 months)
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.