Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
- Trial number:
- NCT04861077
- Trial phase:
- 1
- Study type:
- Any
- Overall status:
- Recruiting
Study start date
June, 2025
Scientific title
Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
Summary
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 oldTriple 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)
Study design
Primary purpose:
Diagnostic, Allocation:
N/A, Intervention model:
Single Group Assignment, Masking:
None (Open Label),
Conditions
Triple Negative Breast Cancer
Other study ID numbers
R21-072