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).
Overview
- Phase
- Early Phase 1
- Intervention
- Lumason
- Conditions
- Breast Cancer
- Sponsor
- Milton S. Hershey Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
- Status
- Withdrawn
- Last Updated
- 4 months ago
Overview
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.
Investigators
Stephanie Patton
Compliance Specialist-RQA
Milton S. Hershey Medical Center
Eligibility Criteria
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))
Arms & Interventions
Contrast Enhanced Ultrasound (with Lumason)
Intervention: Lumason
Outcomes
Primary Outcomes
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Time Frame: No later than week 9
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Time Frame: No later than week 13
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Time Frame: Day 0 (Baseline)
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
Time Frame: No later than week 13
Number of subjects who respond to treatment as reported on routine imaging.
Time Frame: No later than week 17
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Time Frame: No later than week 5
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Time Frame: No later than week 9
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Time Frame: Day 0 (Baseline)
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Time Frame: No later than week 5
Secondary Outcomes
- 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)
- Number of subjects having pathologic complete response(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)
- Overall survival (time to subject death)(No later than year 5)