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Responsible Party left the institution and the study will not be started by other investigator
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast Enhanced Ultrasound (with Lumason) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumason | Drug | Up to 4.8mL administered intravenously |
|
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Hardy, M.D. | Assistant Professor - Department of Radiology, Penn State Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
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| 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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