Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).

December 3, 2025 updated by: Stephanie Patton, Milton S. Hershey Medical Center
To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Willingness and ability to sign and date the study-specific informed consent form.
  • Stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study.
  • Age greater than 18yo.
  • Stage I-III TNBC or stage IV TNBC with intact breast primary.
  • Planned combined ICI therapy as per SoC by treating oncologist.

Exclusion Criteria:

  • Other clinical trials are not excluded but participation must be cleared with the other clinical trial PIs.
  • Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Contrast Enhanced Ultrasound (with Lumason)
Drug: Lumason
Up to 4.8mL administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Time Frame: Day 0 (Baseline)
Day 0 (Baseline)
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Time Frame: No later than week 5
No later than week 5
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Time Frame: No later than week 9
No later than week 9
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Time Frame: Day 0 (Baseline)
Day 0 (Baseline)
Number of subjects who respond to treatment as reported on routine imaging.
Time Frame: No later than week 17
No later than week 17
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Time Frame: No later than week 13
No later than week 13
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Time Frame: No later than week 5
No later than week 5
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Time Frame: No later than week 9
No later than week 9
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
Time Frame: No later than week 13
No later than week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in area under the curve (CEUS metric) between Baseline & C2
Time Frame: No later than year 5
No later than year 5
Number of subjects having pathologic complete response
Time Frame: No later than year 5
No later than year 5
Overall survival (time to subject death)
Time Frame: No later than year 5
No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C3
Time Frame: No later than year 5
No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C4
Time Frame: No later than year 5
No later than year 5
Change in area under the curve (CEUS metric) between C2 & C3
Time Frame: No later than year 5
No later than year 5
Change in area under the curve (CEUS metric) between C2 & C4
Time Frame: No later than year 5
No later than year 5
Change in area under the curve (CEUS metric) between C3 & C4
Time Frame: No later than year 5
No later than year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Seth Hardy, M.D., Assistant Professor - Department of Radiology, Penn State Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 24, 2023

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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