Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University

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