Clinical trial · Interventional
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound
NCT04721886CI-TRIAL-00107156completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast - Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| Perflutren Lipid Microcpheres | Drug | — | UNRESOLVED |
| Ultrasonsgraphy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CEUS)
- description
- Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
- interventionNames
- Procedure: Ultrasonsgraphy
- Drug: Perflutren Lipid Microcpheres
- Procedure: Contrast - Enhanced Ultrasound
Primary outcomes (1)
- measure
- Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP)
- timeFrame
- during the procedure (approximately 90 minutes)
- description
- Pearson's correlation coefficients will be computed between SHAPE results and direct IFP measurements by Stryker compartment pressure monitoring system. A Pearson's correlation coefficient above 0.5 will be considered a successful outcome.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.