Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
About this study
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.
- Condition
- Triple Negative Breast Cancer
- Tested
- [18F]FMISO-PET with contrast-enhanced MRI
- Sponsor
- University of Alabama at Birmingham
Who can join
- Age
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
Inclusion 13
- Minimum age: 18 years
- Maximum age: 75 years
- Eligible sex: Female
- Study condition: Triple Negative Breast Cancer
- 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)
Exclusion 7
- 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
1 site, 1 recruiting
UAB
Birmingham, Alabama, United States
Contact
-
Sebastian Eady
205-996-2636 smeady@uabmc.edu
Potential match only. Final eligibility is determined by the study team.