Breast Cancer Clinical Trial

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

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Full 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.

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Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

25

Study ID:

NCT04721886

Recruitment Status:

Recruiting

Sponsor:

Thomas Jefferson University

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There is 1 Location for this study

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Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Kibo Nam, MD
Contact
215-955-6261
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

25

Study ID:

NCT04721886

Recruitment Status:

Recruiting

Sponsor:


Thomas Jefferson University

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