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Recruiting NCT07225114

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

Phase II Interventional Breast Cancer Kidney Neoplasms Liver Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: contrast agent perflutren lipid, Ultrasound Imaging.
Who it may be relevant to
Registry conditions: Breast Cancer, Kidney Neoplasms, Liver Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug contrast agent perflutren lipid
    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.
  • Device Ultrasound Imaging
    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.

Primary outcome measures

  • Sensitivity 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 [Time frame: Biopsy date (Up to 2 months)]
  • Sensitivity 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 [Time frame: Biopsy date (Up to 2 months)]
  • Sensitivity 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 [Time frame: Biopsy date (Up to 2 months)]
Secondary outcome measures (3)
  • Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast [Time frame: Biopsy date (Up to 2 months)]
  • Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney [Time frame: Biopsy date (Up to 2 months)]
  • Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver [Time frame: Biopsy date (Up to 2 months)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
  • Unstable angina.
  • Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
  • Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
  • Pulmonary hypertension
  • Cardiac shunts

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • The University of North Carolina — Chapel Hill

Identifiers

NCT: NCT07225114 · LCCC2451 · R01CA220681

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗