drugset / Trial / NCT04861077
Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 18F-fluoromisonidazole | Diagnostic / imaging agent | 370 mbq | Intravenous |
| Background | Gadoteridol | Diagnostic / imaging agent | — | — |