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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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))

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline

Timeframe: Day 0 (Baseline)

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2

Timeframe: No later than week 5

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3

Timeframe: No later than week 9

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4

Timeframe: No later than week 13

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline

Timeframe: Day 0 (Baseline)

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2

Timeframe: No later than week 5

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3

Timeframe: No later than week 9

Trial details

NCT IDNCT05957042

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline

Timeframe: Day 0 (Baseline)

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2

Timeframe: No later than week 5

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3

Timeframe: No later than week 9

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4

Timeframe: No later than week 13

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline

Timeframe: Day 0 (Baseline)

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2

Timeframe: No later than week 5

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3

Timeframe: No later than week 9