Private university started a clinical trial of Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer

Thomas Jefferson University is conducting the clinical trial Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer.

This clinical trial studies the use of contrast-enhanced ultrasound (CEUS) in estimating tissue pressure in patients with breast cancer. Diagnostic procedures, such as CEUS, may help estimate tissue pressure noninvasively.

Actual study start date is November 24, 2020. The researchers expect to complete the study by January 1, 2024.

One primary outcome measure is Correlation between subharmonic aided pressure estimation (SHAPE) results and direct measurements of interstitial fluid pressure (IFP). Pearson's correlation coefficients will be computed between SHAPE results and direct IFP measurements by Stryker compartment pressure monitoring system.

Among the exclusion criteria are:

  • Females who are pregnant or nursing.
  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
  • Patients on life support or in a critical care unit
  • Patients with unstable occlusive disease (e.g., crescendo angina)
  • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
  • Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
  • Patients with recent cerebral hemorrhage

and others.

The location of the study is as follows (further details can be found here https://ichgcp.netclinical-trials-registry/NCT04721886) Philadelphia, United States.

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