Breast Cancer, Contrast Enhanced Ultrasound
Conditions
Keywords
Breast Cancer, Contrast Enhanced Ultrasound
Brief summary
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.
Interventions
DRUGLumason
Up to 4.8mL administered intravenously
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects who respond to treatment as reported on routine imaging. | No later than week 17 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 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 |
| Change in area under the curve (CEUS metric) between C2 & C3 | No later than year 5 |
Countries
United States
Outcome results
None listed