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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma
• Intervention / Treatment: Procedure: Ultrasonsgraphy; Drug: Perflutren Lipid Microcpheres; Procedure: Contrast - Enhanced Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provide signed and dated informed consent form
• Be conscious, willing and able to comply with all study procedures and be available for the duration of the study
• At least 21 years old
• Be scheduled for a breast biopsy (Breast Imaging Reporting and Data System [BIRAD] 4, 4A, 4B, 4C or 5)
• Patient with an at least 1 cm mass located at < 3 cm depth, approachable by 2.5 inch needle
• Be medically stable as determined by the investigator
• If a female of child-bearing potential, must have a negative urine pregnancy test within 24 hours prior to administration of Definity

Exclusion Criteria:

• 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
• Patients who have undergone surgery within 24 hours prior to the study sonographic examination
• Patients with known hypersensitivity or allergy to any component of Definity
• Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
• Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (CEUS); Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.	Procedure: Ultrasonsgraphy; Undergo ultrasonography; Other Names: 2-Dimensional Grayscale Ultrasound Imaging; 2-Dimensional Ultrasound Imaging; 2D-US; Ultrasound Imaging; Ultrasound Test; US; Ultrasonography; ultrasound; Medical; Drug: Perflutren Lipid Microcpheres; Given IV; Other Names: Definity; Procedure: Contrast - Enhanced Ultrasound; Undergo CEUS; Other Names: CEUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. A Pearson's correlation coefficient above 0.5 will be considered a successful outcome.	during the procedure (approximately 90 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SHAPE Gradient Values by Malignancy Status	The secondary objective of the study is to determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results. We will use the results from the biopsy as the reference standard. The significance level of Generalized linear mixed logistic or GEE logistic modeling as well as the Mann-Whitney or Student's t-test will be 0.05.	during the procedure (approximately 90 minutes)
Invasive IFP by Malignancy Status	The secondary objective of the study is to determine if the malignancy of breast tumor can be predicted by invasive Interstitial Fluid Pressure (IFP). We will use the results from the biopsy as the reference standard. The significance level of Generalized linear mixed logistic or GEE logistic modeling as well as the Mann-Whitney or Student's t-test will be 0.05.	during the procedure (approximately 90 minutes)

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves; perflutren
• Other Study ID Numbers: 20G.605; R37CA234428 (U.S. NIH Grant/Contract); JT 14830 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No