NCT04721886

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

Completed EARLY_PHASE1 Results posted Last updated 2 April 2026

What this trial tests

EARLY_PHASE1 trial testing Ultrasonsgraphy in Breast Carcinoma in 25 participants. Completed in 11 July 2023.

Timeline

24 November 2020

Primary endpoint
11 July 2023

11 July 2023

Quick facts

Lead sponsor	Thomas Jefferson University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	24 November 2020
Primary completion	11 July 2023
Estimated completion	11 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Ultrasonsgraphy
• Perflutren Lipid Microcpheres — full drug profile →
• Contrast - Enhanced Ultrasound

Conditions studied

• Breast Carcinoma — all drugs for Breast Carcinoma →

Sponsor

Thomas Jefferson University

Who can join

21 and older, female only, with Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Diagnostic (CEUS)	0.2

SHAPE Gradient Values by Malignancy Status Secondary · 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.

Malignant

Group	Value	95% CI
Diagnostic (CEUS)	2.86	± 3.24

Benign

Group	Value	95% CI
Diagnostic (CEUS)	-0.03	± 1.72

Invasive IFP by Malignancy Status Secondary · 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.

Malignant

Group	Value	95% CI
Diagnostic (CEUS)	20.9	± 8.0

Benign

Group	Value	95% CI
Diagnostic (CEUS)	9.9	± 8.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Diagnostic (CEUS)

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (2 terms — click to expand)

Reaction	System	Diagnostic (CEUS)
Transient, brief episode of nausea during infusion	General disorders	—
Dizziness	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04721886 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advocating for the implementation of SonoVue microbubbles as pressure sensors: a call to action for clinical noninvasive pressure estimation.
   Wen A, Yang L, Lv T, Yang H, et al · · 2024 · PMID 39175718 · DOI 10.21037/hbsn-24-193