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
About this trial
This is an interventional diagnostic trial for Breast Carcinoma
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
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
NCT ID
NCT04721886
First Posted
January 19, 2021
Last Updated
September 11, 2023
Sponsor
Thomas Jefferson University
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
Learn more about this trial
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
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