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[18F]FMISO-PET with contrast-enhanced MRI / Triple Negative Breast Cancer · Phase EARLY_PHASE1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered, ongoing Early Phase 1 exploratory study in 20 patients with triple negative breast cancer designed to evaluate whether [18F]FMISO-PET/MRI imaging biomarkers can monitor and predict response to immunotherapy. No results are yet reported in this registry record; the study is currently recruiting and is intended to generate preliminary data for hypothesis generation and future trial design.
Early Phase 1, Interventional, Single Group, Open label, Diagnostic purpose. Triple Negative Breast Cancer; Female; age from 18 Years; to 75 Years. Intervention: Breast [18F]FMISO-PET with contrast-enhanced magnetic reson…. n = 20. 1 site: United States.
This is a registered, ongoing Early Phase 1 exploratory study in 20 patients with triple negative breast cancer designed to evaluate whether [18F]FMISO-PET/MRI imaging biomarkers can monitor and predict response to immunotherapy. No results are yet reported in this registry record; the study is currently recruiting and is intended to generate preliminary data for hypothesis generation and future trial design.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is not yet informative for clinical practice. It is a data-gathering exercise; imaging findings will not guide clinical decisions, and results are not yet available in this registry record.
Early-phase exploratory imaging study in a small planned cohort with no results reported; designed to generate hypothesis-driving data for future trial design.
As stated by the source record.
Quoted from the source exactly as published.
This study is not yet informative for clinical practice. It is a data-gathering exercise; imaging findings will not guide clinical decisions, and results are not yet available in this registry record.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04861077). This is a study registration, not published results. Lead sponsor: University of Alabama at Birmingham. Recruitment status: RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Triple Negative Breast Cancer. Interventions: DRUG: [18F]FMISO-PET with contrast-enhanced MRI. Primary outcome measures: Baseline measure of PET standardized uptake value (SUV). , Baseline; Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. , Baseline. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.