Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT07225114

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

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2026-01-06

40

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

U

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 69 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
Not Eligible

You will not qualify if you...

  • Institutionalized subject (prisoner or nursing home patient)
  • Critically ill or medically unstable with unpredictable critical course (e.g., COPD)
  • Known hypersensitivity to sulfur hexafluoride or any component of perflutren lipid (Definity�AE)
  • Active cardiac disease including severe congestive heart failure (class IV NYHA)
  • Unstable angina
  • Severe arrhythmia (ventricular tachycardia, flutter fibrillation, ventricular premature complexes near T-wave, multifocal complexes)
  • Myocardial infarction within 14 days before Definity�AE administration
  • Pulmonary hypertension
  • Cardiac shunts

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

D

Desma Jones

CONTACT

M

Markeela Lipscomb

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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