Clinical trial NCT05957042: 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).
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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Contrast Enhanced Ultrasound
Keywords: Breast Cancer
Contrast Enhanced Ultrasound
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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))

Primary outcomes:
measure: Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
timeFrame: Day 0 (Baseline)
measure: Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
timeFrame: No later than week 5
measure: Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
timeFrame: No later than week 9
measure: Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
timeFrame: No later than week 13
measure: Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
timeFrame: Day 0 (Baseline)
measure: Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
timeFrame: No later than week 5
measure: Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
timeFrame: No later than week 9
measure: Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
timeFrame: No later than week 13
measure: Number of subjects who respond to treatment as reported on routine imaging.
timeFrame: No later than week 17
Secondary outcomes:
measure: Change in area under the curve (CEUS metric) between Baseline & C2
timeFrame: No later than year 5
measure: Change in area under the curve (CEUS metric) between Baseline & C3
timeFrame: No later than year 5
measure: Change in area under the curve (CEUS metric) between Baseline & C4
timeFrame: No later than year 5
measure: Change in area under the curve (CEUS metric) between C2 & C3
timeFrame: No later than year 5
measure: Change in area under the curve (CEUS metric) between C2 & C4
timeFrame: No later than year 5
measure: Change in area under the curve (CEUS metric) between C3 & C4
timeFrame: No later than year 5
measure: Number of subjects having pathologic complete response
timeFrame: No later than year 5
measure: Overall survival (time to subject death)
timeFrame: No later than year 5
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health College of Medicine
state: Pennsylvania
Study officials:
affiliation: Assistant Professor - Department of Radiology, Penn State Health
name: Seth Hardy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: