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

Primary Purpose

Breast Carcinoma

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ultrasonsgraphy
Perflutren Lipid Microcpheres
Contrast - Enhanced Ultrasound
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CEUS)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Prediction of malignancy of breast tumor by the 3-dimensional subharmonic aided pressure estimation results
Generalized linear mixed logistic or generalized estimating equations logistic modeling of tumor versus non-tumor samples will be used to explore the potential for using SHAPE results as a novel functional predictor of breast tumor malignancy. Additionally, the subharmonic signal ratio from the tumor will be used to predict the malignancy of breast tumor using a biopsy result as a gold standard. The Mann-Whitney or Student's t-test will be performed depending on the distribution of the results.

Full Information

First Posted
January 19, 2021
Last Updated
September 11, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04721886
Brief Title
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
Official Title
Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CEUS)
Arm Type
Experimental
Arm Description
Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.
Intervention Type
Procedure
Intervention Name(s)
Ultrasonsgraphy
Other Intervention Name(s)
2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography, ultrasound, Ultrasound Imaging, Ultrasound Test, Medical, US
Intervention Description
Undergo ultrasonography
Intervention Type
Drug
Intervention Name(s)
Perflutren Lipid Microcpheres
Other Intervention Name(s)
Definity
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Contrast - Enhanced Ultrasound
Other Intervention Name(s)
CEUS
Intervention Description
Undergo CEUS
Primary Outcome Measure Information:
Title
Correlation between subharmonic aided pressure estimation (SHAPE) results and direct measurements of interstitial fluid pressure (IFP)
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.
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Prediction of malignancy of breast tumor by the 3-dimensional subharmonic aided pressure estimation results
Description
Generalized linear mixed logistic or generalized estimating equations logistic modeling of tumor versus non-tumor samples will be used to explore the potential for using SHAPE results as a novel functional predictor of breast tumor malignancy. Additionally, the subharmonic signal ratio from the tumor will be used to predict the malignancy of breast tumor using a biopsy result as a gold standard. The Mann-Whitney or Student's t-test will be performed depending on the distribution of the results.
Time Frame
At baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kibo Nam, MD
Phone
215-955-6261
Email
Kibo.Nam@jefferson.edu
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kibo Nam, MD
Phone
215-955-6261
Email
Kibo.Nam@jefferson.edu

12. IPD Sharing Statement

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

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