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

Early Phase 1

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Procedure: Ultrasonsgraphy; Drug: Perflutren Lipid Microcpheres; Procedure: Contrast - Enhanced Ultrasound

• Registration Number: NCT04721886
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Study Timeline

• Study Start: 2020-11-24
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-25
• Primary Completion: 2023-07-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (CEUS)	Ultrasonsgraphy	Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
Diagnostic (CEUS)	Contrast - Enhanced Ultrasound	Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
Diagnostic (CEUS)	Perflutren Lipid Microcpheres	Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.

Primary Outcome Measures

Name	Time	Method
Correlation between subharmonic aided pressure estimation (SHAPE) results and direct measurements of interstitial fluid pressure (IFP)	At baseline	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.

Secondary Outcome Measures

Name	Time	Method
Prediction of malignancy of breast tumor by the 3-dimensional subharmonic aided pressure estimation results	At baseline	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.

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States