Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
NCT ID: NCT04721886
Last Updated: 2024-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
25 participants
INTERVENTIONAL
2020-11-24
2025-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (CEUS)
Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
Ultrasonsgraphy
Undergo ultrasonography
Perflutren Lipid Microcpheres
Given IV
Contrast - Enhanced Ultrasound
Undergo CEUS
Interventions
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Ultrasonsgraphy
Undergo ultrasonography
Perflutren Lipid Microcpheres
Given IV
Contrast - Enhanced Ultrasound
Undergo CEUS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
FEMALE
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20G.605
Identifier Type: -
Identifier Source: org_study_id
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