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

STATUS

Recruiting
End date

Jan 1, 2024
participants needed

25
sponsor

Thomas Jefferson University

Updated on 4 October 2022

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cancer

breast cancer

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.

Details

Condition	Breast Carcinoma
Treatment	Ultrasonsgraphy, Perflutren Lipid Microcpheres, Contrast - Enhanced Ultrasound
Clinical Study Identifier	NCT04721886
Sponsor	Thomas Jefferson University
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
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

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