Using ultrasound to measure tissue pressure in breast cancer patients
Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound
This study is testing if a special type of ultrasound can help measure tissue pressure in breast cancer patients and see if it can predict how serious their tumors are.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04721886 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of contrast-enhanced ultrasound (CEUS) to estimate tissue pressure in patients diagnosed with breast cancer. The primary objective is to evaluate whether 3-dimensional subharmonic aided pressure estimation (SHAPE) can accurately estimate interstitial fluid pressures in breast tumors and surrounding tissues. Additionally, the study aims to determine if the malignancy of the breast tumor can be predicted based on the SHAPE results. Participants will undergo an initial ultrasound followed by the administration of perflutren lipid microspheres and subsequent CEUS imaging.
Who should consider this trial
Good fit: Ideal candidates include women aged 21 and older who are scheduled for a breast biopsy and have a breast mass that meets specific criteria.
Not a fit: Patients who are pregnant, nursing, or medically unstable are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive method for assessing tissue pressure and predicting tumor malignancy in breast cancer patients.
How similar studies have performed: While the use of CEUS in breast cancer is emerging, this specific application of SHAPE for estimating tissue pressure is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Kibo Nam, MD
- Email: Kibo.Nam@jefferson.edu
- Phone: 215-955-6261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.