Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
Recruiting now · Early Phase 1
Conditions studied: Triple Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT04861077
- Run by
- University of Alabama at Birmingham
- People needed
- 20
- Starts
- 2026-06-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be ≥ 18 years old and ≤ 75 years old
- Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
- >50%Programmed death-ligand 1 (PD-L1) positive
- Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
- May not be pregnant or breastfeeding
- Subjects must be willing to sign consent
- Adequate creatinine clearance per institutional guidelines and within 30 days
- Estimated life expectancy of greater than one year
- Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)
You may not qualify if…
- Inability to provide informed consent
- Weight over 350 lbs., due to the scanner bore size
- Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.
- Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
- Unable to lie still on the imaging table for one (1) hour
- contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
- Have received immunotherapy in the neoadjuvant or adjuvant setting
Where it is running
- UAB — Birmingham, Alabama, United States (enrolling)
Full record on ClinicalTrials.gov
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