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Clinical trial

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).

ID
Name
22769
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2026-09-01
Trial end
2031-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Lumason
Up to 4.8mL administered intravenously
Arms:
Contrast Enhanced Ultrasound (with Lumason)
Size
20
Primary endpoint
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
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))
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Evaluate whether CEUS can predict response on gold standard imaging in the same individuals', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-10-31

1 organization

1 product

2 indications

Organization
Milton S. Hershey Medical Center
Product
Lumason
Indication
Breast Cancer
Indication
Contrast-Enhanced Ultrasound