Status:
RECRUITING
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
Lead Sponsor:
Thomas Jefferson University
Conditions:
Breast Carcinoma
Eligibility:
FEMALE
21+ years
Phase:
EARLY_PHASE1
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04721886
Start Date
November 24 2020
End Date
January 1 2025
Last Update
February 15 2024
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107