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HER2 Positive Breast Cancer / [18F]FMISO PET/MRI imaging · Phase 1 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registry record for an ongoing imaging study examining whether [18F]FMISO PET/MRI can monitor neoadjuvant trastuzumab response in HER2+ breast cancer. No results are posted; the study is in recruitment phase and aims to characterise imaging biomarkers (SUV, ADC, SER) at baseline and over 6 months, with the explicit statement that findings will not alter individual patient treatment.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Diagnostic purpose. HER2-positive Breast Cancer; Female; age from 18 Years. Intervention: Herceptin monotherapy cohort; Combination therapy cohort. n = 25. 1 site: United States.
This is a Phase 1 registry record for an ongoing imaging study examining whether [18F]FMISO PET/MRI can monitor neoadjuvant trastuzumab response in HER2+ breast cancer. No results are posted; the study is in recruitment phase and aims to characterise imaging biomarkers (SUV, ADC, SER) at baseline and over 6 months, with the explicit statement that findings will not alter individual patient treatment.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This is a biomarker discovery and feasibility study. No clinical treatment decisions should be informed by this registry record, as results are not yet available and the study is explicitly not designed to change individual patient management.
Phase 1 interventional imaging study with no posted results; designed to evaluate feasibility and imaging biomarkers in a small cohort, not yet powered to support clinical decisions.
As stated by the source record.
Quoted from the source exactly as published.
This is a biomarker discovery and feasibility study. No clinical treatment decisions should be informed by this registry record, as results are not yet available and the study is explicitly not designed to change individual patient management.
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 (NCT04332588). This is a study registration, not published results. Lead sponsor: University of Alabama at Birmingham. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 25 participants (ESTIMATED). Conditions: HER2-positive Breast Cancer. Interventions: DRUG: [18F]FMISO PET/MRI imaging. 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; Baseline measure of signal enhancement ratio (SER) from MRI. , Baseline; Changes in SER from MRI , Baseline through 6 months; Changes in ADC from MRI , Baseline through 6 months; Changes in SUV from PET , Baseline through 6 months. Brief summary: The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.