Breast CarcinomaEarly Phase 1NCT04721886

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

A Early Phase 1 study testing Ultrasonsgraphy, Perflutren Lipid Microcpheres and Contrast - Enhanced Ultrasound in people with Breast Carcinoma, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older, women only
Conditions the study is for: Breast Carcinoma
What is being tested?: Ultrasonsgraphy, Perflutren Lipid Microcpheres and Contrast - Enhanced Ultrasound
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited States
Study dates: 24 Nov 2020to 11 Jul 2023
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound

Read the detailed description

PRIMARY OBJECTIVE:

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:

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.

Conditions: Breast Carcinoma
Being tested: Ultrasonsgraphy, Perflutren Lipid Microcpheres, Contrast - Enhanced Ultrasound
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UltrasonsgraphyProcedure or surgery
Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography
Undergo ultrasonography
Perflutren Lipid MicrocpheresDrug
Also called Definity
Given IV
Contrast - Enhanced UltrasoundProcedure or surgery
Also called CEUS
Undergo CEUS

Study groups in NCT04721886
Study group	Role	What they receive
Diagnostic (CEUS)	Experimental	Patients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS. Receives: Procedure: Ultrasonsgraphy; Drug: Perflutren Lipid Microcpheres; Procedure: Contrast - Enhanced Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: during the procedure (approximately 90 minutes)

Secondary outcomes (2)

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.
Measured: during the procedure (approximately 90 minutes)
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.
Measured: during the procedure (approximately 90 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 202011 Jul 2023

First posted25 Jan 2021
Study start24 Nov 2020
Primary completion11 Jul 2023
Study completion11 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CarcinomaStudies of the same condition, open and under way.
More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04721886
Sponsor's protocol ID: 20G.605
Other IDs: JT 14830, R37CA234428
Status last verified: Mar 2026
First submitted: 19 Jan 2021
Last updated: 2 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interstitial Fluid Pressure Estimation in Breast Cancer Using 3D Subharmonic Signals From Contrast-Enhanced Ultrasound
ClinicalTrials.gov ID: NCT04721886
Acronym / sponsor ID: 20G.605
Conditions: Breast Carcinoma
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 24 Nov 2020 (actual)
Primary completion: 11 Jul 2023 (actual)
Study completion: 11 Jul 2023 (actual)
First posted: 25 Jan 2021 (actual)
Results: Posted 2 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

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:

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (CEUS)	Experimental	Procedure: Ultrasonsgraphy, Drug: Perflutren Lipid Microcpheres, Procedure: Contrast - Enhanced UltrasoundPatients undergo ultrasound without contrast. Patients then receive Definity IV over 15 minutes and undergo CEUS.

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UltrasonsgraphyAlso: 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, UltrasonographyUndergo ultrasonography	Procedure or surgery	Diagnostic (CEUS)
Perflutren Lipid MicrocpheresAlso: DefinityGiven IV	Drug	Diagnostic (CEUS)
Contrast - Enhanced UltrasoundAlso: CEUSUndergo CEUS	Procedure or surgery	Diagnostic (CEUS)

Primary outcome

Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP)
Time frame: 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.

2 secondary outcomes

SHAPE Gradient Values by Malignancy Status
Time frame: during the procedure (approximately 90 minutes)
Invasive IFP by Malignancy Status
Time frame: during the procedure (approximately 90 minutes)

Results and safety

Results posted to the registry on 2 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (CEUS)	25	24

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

Time frame: during the procedure (approximately 90 minutes). Number. Unit: Correlation coefficient (Pearson's r)

Measure	Diagnostic (CEUS) n = 21
Value	0.2

Diagnostic (CEUS): p = 0.42, Pearson's correlation coefficient

2 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (CEUS)	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Carcinoma

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation Between Subharmonic Aided Pressure Estimation (SHAPE) Results and Direct Measurements of Interstitial Fluid Pressure (IFP) (time frame: during the procedure (approximately 90 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04721886.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.