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).

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Breast Cancer, Contrast Enhanced Ultrasound

Intervention / Treatment
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* Drug: Lumason


Participation Criteria
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Eligibility Criteria
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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))

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast Enhanced Ultrasound (with Lumason)<br> | Drug: Lumason<br>* Up to 4.8mL administered intravenously<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Contrast Enhanced Ultrasound