Actively Recruiting
Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
Led by University of Alabama at Birmingham · Updated on 2026-02-20
20
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.
CONDITIONS
Official Title
Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older and 75 years or younger
- Biopsy-proven triple negative breast cancer (TNBC) stage II-IV
- More than 50% Programmed death-ligand 1 (PD-L1) positive
- Eligible for immunotherapy and have not started any immunotherapy treatment
- Not pregnant or breastfeeding
- Willing to sign consent
- Adequate creatinine clearance within 30 days
- Estimated life expectancy greater than one year
- At least one lesion with RECIST measurable disease greater than 1 cm in diameter
You will not qualify if you...
- Unable to provide informed consent
- Weight over 350 lbs due to scanner size
- Lactating, known or suspected pregnancy; negative pregnancy test required before PET imaging
- Contraindications for MRI such as non-removable metal implants or certain tattoos
- Unable to lie still for one hour during imaging
- Contraindication for gadolinium-based contrast agent Prohance (gadoteridol)
- Have received immunotherapy in the neoadjuvant or adjuvant setting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UAB
Birmingham, Alabama, United States, 35249
Actively Recruiting
Research Team
S
Sebastian Eady
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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