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).

NCT05957042 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 22769
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Enhanced Ultrasound; Breast Cancer

Keywords

Breast Cancer; Contrast Enhanced Ultrasound

Outcome Measures

Primary Outcomes (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

• 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 C2

  No later than week 5

• Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3

  No later than week 9

• 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

Secondary Outcomes (8)

• 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

• Change in area under the curve (CEUS metric) between C2 & C4

  No later than year 5

Study Arms (1)

Contrast Enhanced Ultrasound (with Lumason)

EXPERIMENTAL

Drug: Lumason

Interventions

Lumason DRUG

Up to 4.8mL administered intravenously

Contrast Enhanced Ultrasound (with Lumason)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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))

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Health College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seth Hardy, M.D.

  Assistant Professor - Department of Radiology, Penn State Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Compliance Specialist-RQA

Model Details: Evaluate whether CEUS can predict response on gold standard imaging in the same individuals

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 24, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)