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| ID | Type | Description | Link |
|---|---|---|---|
| JT 14830 | Other Identifier | JeffTrial Number | |
| R37CA234428 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (CEUS) | Experimental | Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonsgraphy | Procedure | Undergo ultrasonography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| SHAPE Gradient Values by Malignancy Status | 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. | during the procedure (approximately 90 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
One participant was determined to be ineligible after enrollment and three participants' data were not correctly collected.
Subjects eligible for trial enrollment will be identified by the investigators from the TJU patient population who are scheduled for a breast biopsy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (CEUS) | Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS. Ultrasonsgraphy: Undergo ultrasonography Perflutren Lipid Microcpheres: Given IV Contrast - Enhanced Ultrasound: Undergo CEUS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A total of 25 participants were consented for the study. 1 participant was determined to be ineligible after consent. Of the 24 eligible participants, 3 did not initiate the study procedures and were excluded prior to assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (CEUS) | Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS. Ultrasonsgraphy: Undergo ultrasonography Perflutren Lipid Microcpheres: Given IV Contrast - Enhanced Ultrasound: Undergo CEUS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Correlation coefficient (Pearson's r) | during the procedure (approximately 90 minutes) |
|
The subjects will be monitored for AEs and SAEs up to 90 minutes on day of procedure (including CEUS procedure and 30 minute post-procedure monitoring). All AEs, including observed or volunteered problems, complaints, signs or symptoms, and diagnoses, occurring from the initiation of Definity dosing until the completion of the Definity administration will be recorded on a serious or non-serious AE data form, whether or not associated with the use of the trial medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (CEUS) | Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS. Ultrasonsgraphy: Undergo ultrasonography Perflutren Lipid Microcpheres: Given IV Contrast - Enhanced Ultrasound: Undergo CEUS |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient, brief episode of nausea during infusion | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kibo Nam, MD | Thomas Jefferson University | 215-955-6261 | Kibo.Nam@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2021 | Jul 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| C042852 | perflutren |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Perflutren Lipid Microcpheres | Drug | Given IV |
|
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| Contrast - Enhanced Ultrasound | Procedure | Undergo CEUS |
|
|
| Invasive IFP by Malignancy Status | 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. | during the procedure (approximately 90 minutes) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Secondary | SHAPE Gradient Values by Malignancy Status | 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. | A total of 25 participants were consented for the study. 1 participant was determined to be ineligible after consent. Of the 24 eligible participants, 3 did not initiate the study procedures and were excluded prior to assignment. | Posted | Mean | Standard Deviation | arbitrary units (a.u.) | during the procedure (approximately 90 minutes) | lesions | lesions |
|
|
|
|
| Secondary | Invasive IFP by Malignancy Status | 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. | There were 8 malignant and 13 benign lesions studied. A total of 25 participants were consented for the study. 1 participant was determined to be ineligible after consent. Of the 24 eligible participants, 3 did not initiate the study procedures and were excluded prior to assignment. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | during the procedure (approximately 90 minutes) | lesions | lesions |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 2 |
| 21 |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D055585 |
| Physical Phenomena |
| Benign |
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| Benign |
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