Table 3.
Clinical trials of hypoxia imaging in HNC.
| Study Number | Outcome Measures | Imaging Modality | Tracer | Status | Outcomes | Last Update |
|---|---|---|---|---|---|---|
| NCT03646747 | Feasibility of OE-MRI in detecting tumor hypoxia | OE-MRI | Label-free | Unknown Status | NA | 2018 |
| NCT04724096 | Feasibility of OE-MRI in detecting tumor hypoxia | OE-MRI | Label-free | Completed | OE-MRI was feasible and well-tolerated in detecting hypoxia 113. | 2023 |
| NCT01829646 | Prognostic value of functional MRI in detecting tumor hypoxia | DCE-MRI and DWI-MRI | Label-free | Recruiting | NA | 2023 |
| NCT03510390 | Correlation between hypoxic volume and treatment response | BOLD and DWI | Label-free | Completed | NA | 2021 |
| NCT06041555 | Feasibility of MRI in detecting tumor hypoxia | multiparametric MR | Label-free | Recruiting | NA | 2024 |
| NCT05246475 | Voxel-level correlation of hypoxia MRI and PET estimates in detecting hypoxia | multiparametric MR and PET | 18F-EF5 | Recruiting | NA | 2022 |
| NCT06108089 | Voxel-level correlation of hypoxia MRI and PET estimates in detecting hypoxia | multiparametric MR and PET | 18F-FMISO | Recruiting | NA | 2024 |
| NCT05996432 | Voxel-level correlation of hypoxia MRI and PET estimates in detecting hypoxia | multiparametric MR and PET | 18F-FMISO | Recruiting | NA | 2024 |
| NCT04846309 | Evaluating the safety and efficiency in hypoxia-guided dose-escalated radiotherapy | multiparametric MR and PET | 18F-FMISO | Recruiting | NA | 2025 |
| NCT02352792 | Prognostic value and relevant toxicity for hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FMISO | Completed | No relevant toxicities were detected; the dose escalation group experienced a local control benefit 90,111. | 2015 |
| NCT01212354 | Evaluation of 2-year local control in hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FMISO | Recruiting | The dose escalation group experienced a 15% local control benefit 92. | 2016 |
| NCT01235052 | Correlation between hypoxic volume and treatment response | PET/CT | 18F-FMISO | Completed | NA | 2017 |
| NCT00180180 | Correlation of hypoxia between primary tumors and lymph node metastases (LNM) | PET/CT | 18F-FMISO | Completed | A significant correlation between FMISO-based hypoxia was observed in the primary tumor and large LNMs 103. | 2020 |
| NCT00606294 | Evaluating the safety and efficiency in hypoxia-guided treatment optimization | PET/CT | 18F-FMISO | Completed | No adverse events were observed; all patients are in the follow-up stage. | 2023 |
| NCT00606294 | Correlation between hypoxic volume and distant metastasis (DM) | PET/CT | 18F-FMISO | Completed | Persistent hypoxia was associated with increased DM risk and worse OS 104. | 2023 |
| NCT04995185 | Evaluating the feasibility and efficiency of hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FMISO | Completed | NA | 2024 |
| NCT05348486 | Evaluating the feasibility and efficiency of hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FMISO | Recruiting | NA | 2025 |
| NCT05544136 | Evaluation of overall survival (OS) in hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FMISO | Recruiting | NA | 2025 |
| NCT06087614 | Prognostic value and relevant toxicity for hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FMISO | Recruiting | NA | 2025 |
| NCT02207439 | Correlation between hypoxic volume and treatment response | PET/CT | 18F-FMISO or 18F-EF5 | Completed | NA | 2023 |
| NCT01017224 | Correlation between baseline hypoxia and treatment response | PET/CT | 18F-FAZA | Completed | The TMR ≥1.6 at baseline was markedly associated with treatment failure 45. | 2012 |
| NCT02976051 | Evaluating the efficiency of hypoxia-guided dose-escalated radiotherapy | PET/CT | 18F-FAZA | Completed | The dose escalation group achieved a local control benefit of 20% 95. | 2020 |
| NCT01075399 | Evaluating the repeatability of all parameters in hypoxia PET imaging | PET/CT | 18F-HX4 | Completed | All parameters were significantly correlated between scans 46. | 2013 |
| NCT01347281 | Prognostic value for dynamic PET imaging of tumor hypoxia | PET/CT | 18F-HX4 | Completed | Dynamic changes of hypoxia correlated with prognostic outcome 93. | 2017 |
| NCT02976883 | Correlation between hypoxic volume and treatment response | PET/CT | 18F-HX4 | Completed | NA | 2019 |
| NCT03003637 | Correlation between hypoxic volume and treatment response | PET/CT | 18F-HX4 | Completed | An on-treatment decrease in hypoxia signature was observed in responders to immunotherapy 97. | 2023 |
| NCT06716892 | Evaluating the potential of preoperative hypoxia detection in HNC | PAI | Label-free | Recruiting | NA | 2024 |
HNC: head and cancer; PET: positron emission tomography; CT: computed tomography; MR: magnetic resonance; MRI: magnetic resonance imaging; OE-MRI: oxygen-enhanced magnetic resonance imaging; DCE: dynamic contrast-enhanced magnetic resonance imaging; DWI-MRI: diffusion-weighted magnetic resonance imaging; PAI: photoacoustic imaging; NA: not available.