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.
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
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)
Single group
[18F]FMISO-PET with contrast-enhanced MRI
DrugTriple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle.
Baseline measure of PET standardized uptake value (SUV).
Compare baseline metrics from PET/MRI
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Compare baseline metrics from PET/MRI.
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