Using ultrasound to predict treatment response in breast cancer patients
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).
EARLY_PHASE1 · Milton S. Hershey Medical Center · NCT05957042
This study is testing if a special type of ultrasound can help predict how well treatment works for people with triple negative breast cancer who are getting chemotherapy and immune therapy.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center (other) |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05957042 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of contrast enhanced ultrasound (CEUS) in predicting treatment response in patients with triple negative breast cancer (TNBC) who are receiving combined chemotherapy and immune checkpoint inhibitors. The study will assess whether CEUS can provide earlier indications of treatment efficacy compared to standard imaging methods like MRI or CT scans. Participants will receive the ultrasound intervention, Lumason, to monitor their response to therapy throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with stage I-III TNBC or stage IV TNBC with an intact breast primary who are scheduled to receive combined immune checkpoint inhibitor therapy.
Not a fit: Patients who are pregnant, have known allergies to ultrasound contrast agents, or are unsuitable for CEUS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of treatment response, allowing for timely adjustments in therapy for TNBC patients.
How similar studies have performed: While this approach is novel in the context of TNBC and CEUS, similar imaging techniques have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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))
Where this trial is running
Hershey, Pennsylvania
- Penn State Health College of Medicine — Hershey, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Seth Hardy, M.D. — Assistant Professor - Department of Radiology, Penn State Health
- Study coordinator: Rebecca Jordan, M.A.
- Email: rjordan@pennstatehealth.psu.edu
- Phone: 717-531-0003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Contrast Enhanced Ultrasound