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Completed

NCT Number: NCT04721886

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

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.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

PRIMARY OBJECTIVE:

I. To determine if the 3-dimensional (3D) subharmonic aided pressure estimation (SHAPE) results can be used to estimate interstitial fluid pressures (IFPs) in breast tumor and its surrounding tissue.

SECONDARY OBJECTIVE:

I. To determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results.

OUTLINE:

Patients undergo ultrasound without contrast. Patients then receive perflutren lipid microspheres (Definity) intravenously (IV) over 15 minutes and undergo CEUS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonsgraphy

Procedure

Undergo ultrasonography

Other names: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, ultrasound, Ultrasound Imaging, Ultrasound Test, Medical, US

Perflutren Lipid Microcpheres

Drug

Given IV

Other names: Definity

Contrast - Enhanced Ultrasound

Procedure

Undergo CEUS

Other names: CEUS

Primary outcomes

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

    Time frame: during the procedure (approximately 90 minutes)

    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

  1. SHAPE Gradient Values by Malignancy Status

    Time frame: during the procedure (approximately 90 minutes)

    The secondary objective of the study is to determine if the malignancy of breast tumor can be predicted by the 3D SHAPE results. We will use the results from the biopsy as the reference standard. The significance level of Generalized linear mixed logistic or GEE logistic modeling as well as the Mann-Whitney or Student's t-test will be 0.05.

  2. Invasive IFP by Malignancy Status

    Time frame: during the procedure (approximately 90 minutes)

    The secondary objective of the study is to determine if the malignancy of breast tumor can be predicted by invasive Interstitial Fluid Pressure (IFP). We will use the results from the biopsy as the reference standard. The significance level of Generalized linear mixed logistic or GEE logistic modeling as well as the Mann-Whitney or Student's t-test will be 0.05.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2021
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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