Early Phase 1
N=25
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
Breast Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04721886 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP) — 0.2 Correlation coefficient (Pearson's r) — p=0.42
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ultrasonsgraphy (Procedure); Perflutren Lipid Microcpheres (Drug); Contrast - Enhanced Ultrasound (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP) |
0.2 | 0.42 |
| SECONDARY SHAPE Gradient Values by Malignancy Status |
2.86; -0.03 | 0.03 sig |
| SECONDARY Invasive IFP by Malignancy Status |
20.9; 9.9 | 0.008 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04721886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.