drugset / Trial / NCT04861077

Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

NCT04861077

Phase 0 Recruiting 20 enrolled University of Alabama at Birmingham
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2026-06
Primary completion
2028-08
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-fluoromisonidazole Diagnostic / imaging agent 370 mbq Intravenous
Background Gadoteridol Diagnostic / imaging agent