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

NCT04721886 | Completed Early Phase 1 Results FDA Drug

• 3 other identifiers: 20G.605JT 14830R37CA234428
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP)

  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.

  during the procedure (approximately 90 minutes)

Secondary Outcomes (2)

• SHAPE Gradient Values by Malignancy Status

  during the procedure (approximately 90 minutes)

• Invasive IFP by Malignancy Status

  during the procedure (approximately 90 minutes)

Study Arms (1)

Diagnostic (CEUS)

EXPERIMENTAL

Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.

Procedure: Ultrasonsgraphy; Drug: Perflutren Lipid Microcpheres; Procedure: Contrast - Enhanced Ultrasound

Interventions

Perflutren Lipid Microcpheres DRUG

Given IV

Also known as: Definity

Diagnostic (CEUS)

Contrast - Enhanced Ultrasound PROCEDURE

Undergo CEUS

Also known as: CEUS

Diagnostic (CEUS)

Ultrasonsgraphy PROCEDURE

Undergo ultrasonography

Also known as: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, ultrasound, Ultrasound Imaging, Ultrasound Test, Medical, US

Diagnostic (CEUS)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves; perflutren

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Results Point of Contact

• Title: Kibo Nam, MD
• Organization: Thomas Jefferson University

Kibo.Nam@jefferson.edu

215-955-6261

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: November 24, 2020
• Primary Completion: July 11, 2023
• Study Completion: July 11, 2023
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Locations

US (1)