Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in … (NCT05957042) | Clinical Trial Compass
WithdrawnEarly Phase 1
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).
Stopped: Responsible Party left the institution and the study will not be started by other investigator
United States0Started 2023-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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))
What they're measuring
1
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Timeframe: Day 0 (Baseline)
2
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Timeframe: No later than week 5
3
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Timeframe: No later than week 9
4
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Timeframe: No later than week 13
5
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Timeframe: Day 0 (Baseline)
6
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Timeframe: No later than week 5
7
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Timeframe: No later than week 9
8
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4