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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721886
• Other study ID #: 20G.605
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 24, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: Kibo Nam, MD
• Phone: 215-955-6261
• Email: Kibo.Nam[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 1, 2025
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms

Intervention

Procedure:
• Ultrasonsgraphy
Undergo ultrasonography

Drug:
• Perflutren Lipid Microcpheres
Given IV

Procedure:
• Contrast - Enhanced Ultrasound
Undergo CEUS

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline
Secondary	Prediction of malignancy of breast tumor by the 3-dimensional subharmonic aided pressure estimation results	Generalized linear mixed logistic or generalized estimating equations logistic modeling of tumor versus non-tumor samples will be used to explore the potential for using SHAPE results as a novel functional predictor of breast tumor malignancy. Additionally, the subharmonic signal ratio from the tumor will be used to predict the malignancy of breast tumor using a biopsy result as a gold standard. The Mann-Whitney or Student's t-test will be performed depending on the distribution of the results.	At baseline