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).

Breast Cancer Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05957042
• Other study ID #: 22769
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 1, 2023
• Est. completion date: September 1, 2031

Study information

• Verified date: October 2023
• Source: Milton S. Hershey Medical Center
• Contact: Rebecca Jordan, M.A.
• Phone: 717-531-0003
• Email: rjordan[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2031
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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))

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Contrast Enhanced Ultrasound
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Lumason
Up to 4.8mL administered intravenously

Locations

Country	Name	City	State
United States	Penn State Health College of Medicine	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline		Day 0 (Baseline)
Primary	Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2		No later than week 5
Primary	Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3		No later than week 9
Primary	Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4		No later than week 13
Primary	Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline		Day 0 (Baseline)
Primary	Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2		No later than week 5
Primary	Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3		No later than week 9
Primary	Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4		No later than week 13
Primary	Number of subjects who respond to treatment as reported on routine imaging.		No later than week 17
Secondary	Change in area under the curve (CEUS metric) between Baseline & C2		No later than year 5
Secondary	Change in area under the curve (CEUS metric) between Baseline & C3		No later than year 5
Secondary	Change in area under the curve (CEUS metric) between Baseline & C4		No later than year 5
Secondary	Change in area under the curve (CEUS metric) between C2 & C3		No later than year 5
Secondary	Change in area under the curve (CEUS metric) between C2 & C4		No later than year 5
Secondary	Change in area under the curve (CEUS metric) between C3 & C4		No later than year 5
Secondary	Number of subjects having pathologic complete response		No later than year 5
Secondary	Overall survival (time to subject death)		No later than year 5