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).

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05957042
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 96
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Contrast Enhanced Ultrasound	Drug: Lumason	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Evaluate whether CEUS can predict response on gold standard imaging in the same individualsEvaluate whether CEUS can predict response on gold standard imaging in the same individuals
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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).
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2026
• Anticipated Study Completion Date: Aug 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Contrast Enhanced Ultrasound (with Lumason)	Drug: Lumason; Up to 4.8mL administered intravenously

Outcome Measures

Primary Outcome Measures

1. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline [Day 0 (Baseline)]

2. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2 [No later than week 5]

3. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3 [No later than week 9]

4. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline [Day 0 (Baseline)]

5. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C1 [No later than week 5]

6. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2 [No later than week 9]

7. Number of subjects who respond to treatment as reported on routine imaging. [No later than week 17]

Secondary Outcome Measures

1. Change in area under the curve (CEUS metric) between Baseline & C1 [No later than year 5]

2. Change in area under the curve (CEUS metric) between Baseline & C2 [No later than year 5]

3. Change in area under the curve (CEUS metric) between C1 & C2 [No later than year 5]

4. Number of subjects having pathologic complete response [No later than year 5]

5. Overall survival (time to subject death) [No later than year 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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))

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State Health College of Medicine	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Seth Hardy, M.D., Assistant Professor - Department of Radiology, Penn State Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seth Hardy, Assistant Professor - Department of Radiology, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT05957042
• Other Study ID Numbers: 22769
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Seth Hardy, Assistant Professor - Department of Radiology, Milton S. Hershey Medical Center: Breast Cancer; Contrast Enhanced Ultrasound
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Jul 24, 2023