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 1WithdrawnNCT05957042

Milton S. Hershey Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Breast Cancer Contrast Enhanced Ultrasound

Interventions

LumasonDRUG

Up to 4.8mL administered intravenously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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))

Locations (1)

Penn State Health College of Medicine

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline

Time frame: Day 0 (Baseline)

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2

Time frame: No later than week 5

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3

Time frame: No later than week 9

Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4

Time frame: No later than week 13

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

Time frame: Day 0 (Baseline)

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2

Time frame: No later than week 5

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

Time frame: No later than week 9

Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4

Time frame: No later than week 13

Number of subjects who respond to treatment as reported on routine imaging.

Time frame: No later than week 17

Secondary Outcomes

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

Time frame: No later than year 5

Data from ClinicalTrials.gov

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