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).

Penn State Health

Status and phase: Enrolling; Early Phase 1

Conditions: Breast Cancer; Contrast Enhanced Ultrasound

Treatments: Drug: Lumason

Study type: Interventional

Funder types: Other

Identifiers

NCT05957042

22769

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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))

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Contrast Enhanced Ultrasound (with Lumason)

Experimental group

Treatment:

Drug: Lumason