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NCT04861077 · ClinicalTrials.gov record · last posted 2026-08-17

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

StatusRecruiting
PhaseEarly Phase 1
Started2027-06
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from the ClinicalTrials.gov record
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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-18
Primary completion pushed: 2028-08 → 2030-08
2026-08-18
Completion pushed: 2028-08 → 2030-08
Trial Details
NCT Number NCT04861077
Lead Sponsor University of Alabama at Birmingham
Conditions Triple Negative Breast Cancer
Enrollment 20 participants
Start Date 2027-06
Primary Completion 2030-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-17