NCT04721886

Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer

Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue. SECONDARY OBJECTIVE: I. To determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results. OUTLINE: Patients undergo ultrasound without contrast. Patients then receive perflutren lipid microspheres (Definity) intravenously (IV) over 15 minutes and undergo CEUS.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Ultrasonsgraphy	Undergo ultrasonography
DRUG	Perflutren Lipid Microcpheres	Given IV
PROCEDURE	Contrast - Enhanced Ultrasound	Undergo CEUS

Timeline

• Start date: 2020-11-24
• Primary completion: 2023-07-11
• Completion: 2023-07-11
• First posted: 2021-01-25
• Last updated: 2026-04-02
• Results posted: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study