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Trial 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).
NCT ID:
NCT05957042
Condition:
Breast Cancer
Contrast Enhanced Ultrasound
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Contrast Enhanced Ultrasound
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Evaluate whether CEUS can predict response on gold standard imaging in the same
individuals
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lumason
Description:
Up to 4.8mL administered intravenously
Arm group label:
Contrast Enhanced Ultrasound (with Lumason)
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.
Criteria for 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))
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Penn State Health College of Medicine
Address:
City:
Hershey
Zip:
17033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Jordan, M.A.
Phone:
717-531-0003
Email:
rjordan@pennstatehealth.psu.edu
Start date:
September 1, 2023
Completion date:
September 1, 2031
Lead sponsor:
Agency:
Milton S. Hershey Medical Center
Agency class:
Other
Source:
Milton S. Hershey Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957042
