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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
    • Ultrasonography
    • ultrasound
    • Ultrasound Imaging
    • Ultrasound Test
    • Medical
    • US
  • Drug: Perflutren Lipid Microcpheres
    Given IV
    Other names:
    • Definity
  • Procedure: Contrast - Enhanced Ultrasound
    Undergo CEUS
    Other names:
    • CEUS

Recruiting Locations

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Kibo Nam, MD
215-955-6261
Kibo.Nam@jefferson.edu

More Details

Status
Recruiting
Sponsor
Thomas Jefferson University

Study Contact

Kibo Nam, MD
215-955-6261
Kibo.Nam@jefferson.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.