Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Thomas Jefferson University
With
National Cancer Institute (NCI)
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.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
