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 Phase 1

Recruiting

• Conditions: Breast Cancer; Contrast Enhanced Ultrasound
• Interventions: Drug: Lumason

• Registration Number: NCT05957042
• Lead Sponsor: Milton S. Hershey Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-24
• Study Start: 2023-09-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-09-01
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast Enhanced Ultrasound (with Lumason)	Lumason	-

Primary Outcome Measures

Name	Time	Method
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 C4	No later than week 13
Number of subjects who respond to treatment as reported on routine imaging.	No later than week 17
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
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

Secondary Outcome Measures

Name	Time	Method
Change in area under the curve (CEUS metric) between Baseline & C2	No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C3	No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C4	No later than year 5
Change in area under the curve (CEUS metric) between C2 & C3	No later than year 5
Number of subjects having pathologic complete response	No later than year 5
Change in area under the curve (CEUS metric) between C2 & C4	No later than year 5
Change in area under the curve (CEUS metric) between C3 & C4	No later than year 5
Overall survival (time to subject death)	No later than year 5

Trial Locations

Locations (1)

Penn State Health College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States