Back to resultsPilot 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).
Primary Purpose
Breast Cancer, Contrast Enhanced Ultrasound
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lumason
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Contrast Enhanced Ultrasound
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))
Sites / Locations
- Penn State Health College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast Enhanced Ultrasound (with Lumason)
Arm Description
Outcomes
Primary Outcome Measures
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
Number of subjects who respond to treatment as reported on routine imaging.
Secondary Outcome Measures
Change in area under the curve (CEUS metric) between Baseline & C2
Change in area under the curve (CEUS metric) between Baseline & C3
Change in area under the curve (CEUS metric) between Baseline & C4
Change in area under the curve (CEUS metric) between C2 & C3
Change in area under the curve (CEUS metric) between C2 & C4
Change in area under the curve (CEUS metric) between C3 & C4
Number of subjects having pathologic complete response
Overall survival (time to subject death)
Full Information
NCT ID
NCT05957042
First Posted
July 12, 2023
Last Updated
August 17, 2023
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05957042
Brief 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).
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Contrast Enhanced Ultrasound
Keywords
Breast Cancer, Contrast Enhanced Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contrast Enhanced Ultrasound (with Lumason)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lumason
Intervention Description
Up to 4.8mL administered intravenously
Primary Outcome Measure Information:
Title
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Time Frame
Day 0 (Baseline)
Title
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Time Frame
No later than week 5
Title
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Time Frame
No later than week 9
Title
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Time Frame
No later than week 13
Title
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Time Frame
Day 0 (Baseline)
Title
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Time Frame
No later than week 5
Title
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Time Frame
No later than week 9
Title
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
Time Frame
No later than week 13
Title
Number of subjects who respond to treatment as reported on routine imaging.
Time Frame
No later than week 17
Secondary Outcome Measure Information:
Title
Change in area under the curve (CEUS metric) between Baseline & C2
Time Frame
No later than year 5
Title
Change in area under the curve (CEUS metric) between Baseline & C3
Time Frame
No later than year 5
Title
Change in area under the curve (CEUS metric) between Baseline & C4
Time Frame
No later than year 5
Title
Change in area under the curve (CEUS metric) between C2 & C3
Time Frame
No later than year 5
Title
Change in area under the curve (CEUS metric) between C2 & C4
Time Frame
No later than year 5
Title
Change in area under the curve (CEUS metric) between C3 & C4
Time Frame
No later than year 5
Title
Number of subjects having pathologic complete response
Time Frame
No later than year 5
Title
Overall survival (time to subject death)
Time Frame
No later than year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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))
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Jordan, M.A.
Phone
717-531-0003
Email
rjordan@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Hardy, M.D.
Organizational Affiliation
Assistant Professor - Department of Radiology, Penn State Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Health College of Medicine
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Jordan, M.A.
Phone
717-531-0003
Email
rjordan@pennstatehealth.psu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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).
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