Trial Outcomes & Findings for Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer (NCT NCT04721886)
NCT ID: NCT04721886
Last Updated: 2026-04-02
Results Overview
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.
COMPLETED
EARLY_PHASE1
25 participants
during the procedure (approximately 90 minutes)
2026-04-02
Participant Flow
Subjects eligible for trial enrollment will be identified by the investigators from the TJU patient population who are scheduled for a breast biopsy.
One participant was determined to be ineligible after enrollment and three participants' data were not correctly collected.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Did not meet eligibility criteria (tumor size below inclusion threshold)
|
1
|
Baseline Characteristics
Contrast-Enhanced Ultrasound Scan for the Estimation of Tissue Pressure in Patients With Breast Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (CEUS)
n=25 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Diagnostic (CEUS)
n=21 Participants
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
|
|---|---|
|
Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP)
|
0.2 Correlation coefficient (Pearson's r)
|
SECONDARY outcome
Timeframe: during the procedure (approximately 90 minutes)Population: 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.
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.
Outcome measures
| Measure |
Diagnostic (CEUS)
n=21 lesions
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
|
|---|---|
|
SHAPE Gradient Values by Malignancy Status
Malignant
|
2.86 arbitrary units (a.u.)
Standard Deviation 3.24
|
|
SHAPE Gradient Values by Malignancy Status
Benign
|
-0.03 arbitrary units (a.u.)
Standard Deviation 1.72
|
SECONDARY outcome
Timeframe: during the procedure (approximately 90 minutes)Population: 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.
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.
Outcome measures
| Measure |
Diagnostic (CEUS)
n=21 lesions
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
|
|---|---|
|
Invasive IFP by Malignancy Status
Malignant
|
20.9 millimeters of mercury (mmHg)
Standard Deviation 8.0
|
|
Invasive IFP by Malignancy Status
Benign
|
9.9 millimeters of mercury (mmHg)
Standard Deviation 8.5
|
Adverse Events
Diagnostic (CEUS)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diagnostic (CEUS)
n=21 participants at risk
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
|
|---|---|
|
General disorders
Transient, brief episode of nausea during infusion
|
4.8%
1/21 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place