An observational study in Glioblastoma Multiforme, sponsored by University of Sydney. Recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University of Sydney · Observational
This study is designed to evaluate the role of Oxygen Enhanced (OE) Magnetic resonance imaging (MRI) and Blood Oxygenation Level Dependent (BOLD) MRI in detecting regions of hypoxic tumour and to evaluate their use as imaging methods to selectively deliver targeted radiotherapy to regions of aggressive disease.
The ability to image tumour hypoxia at diagnosis and prior to radiotherapy is extremely important to appropriately adapt radiotherapy plans such that to selectively deliver higher doses of radiation to those more aggressive tumour subregions, thereby improving the chances to achieve better local tumour control. Preoperative imaging of tumour hypoxia also offers the opportunity for 'supra-marginal resections' in surgical planning beyond current neurosurgical standard of care. Additionally, accurately identifying regions of tumour hypoxia harbouring tumour progression at follow up is fundamental in patient follow-up, allowing multidisciplinary teams to more confidently intervene at an earlier stage of tumour recurrence and personalise therapy tailored to the tumour's response to treatment. Routine imaging of tumour hypoxia is currently challenging, as it requires [18F]-Fluoromisonidazole (18F-FMISO PET) imaging, which is not available in the majority of clinical centres. Today, the availability of accelerated quantitative MRI sequences on clinical MRI systems could enable quantification of tumour hypoxia without putting an unfeasible burden on patients' scan sessions. The next frontier in radiotherapy treatment will use these techniques to identify hypoxic tumour tissues and personalise treatments to the patient's unique tumour biology, maximising the probability of tumour control.
This clinical study will acquire additional images of brain cancer patients. The images will not change the patient's treatment. This study is designed to evaluate the role of oxygen enhanced (OE) MRI and BOLD MRI in detecting regions of hypoxic tumour and to evaluate their use as imaging methods to selectively deliver targeted radiotherapy to regions of aggressive disease.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 188 observational studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Sydney is the lead sponsor of 91 studies on the registry; 25 are open to participants now.
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Histopathological diagnosis of a high grade glioma / glioblastoma multiforme
Exclusion Criteria:
Determination of spatial correlation of hypoxic tumour volume between Magnetic resonance imaging (MRI) and [18F]-Fluoromisonidazole (18F-FMISO) MRI
Spatial correlation between hypoxic tumour volume determined with MRI and 18F-FMISO will be evaluated via measurements of Dice similarity coefficient. Dice similarity coefficients \> 0.9 will be considered a strong spatial correlation. Quantitative correlation of voxel-wise levels of hypoxia will be evaluated via measurement of the Spearman's/Pearson's correlation coefficient. Correlation coefficients \> 0.7 will be considered a strong correlation.
Time frame: 1 year
Repeatability of voxel-wise levels of hypoxia in the tumour
Repeatability of voxel-wise levels of hypoxia in the tumour will be assessed by measurements of intraclass correlation coefficient (ICC).27 ICC values \> 0.9 reflect excellent repeatability, good between 0.75 and 0.9, moderate between 0.5 and 0.75, and poor \< 0.5. Additionally, similarity between the hypoxia tumour volume (HTV) defined with the MRI biomarker at the two timepoints will be assessed via calculation of Dice similarity coefficient. Dice similarity coefficients \> 0.9 will be considered a strong correlation.
Time frame: 1 year
The predicted patient outcomes of the biologically-adapted Radiotherapy (RT) plan will be compared with the actual patient outcomes
The predicted patient outcomes of the biologically-adapted RT plan will be compared with the actual patient outcomes following conventional treatment, by using metrics including tumour control probability (TCP) and toxicity measurement to organs at risks and healthy brain (including equivalent uniform dose). Success for this objective will be achieved if the biologically-adapted RT plans result in improved TCP by at least 10% for all patients over conventional treatment, while toxicity metrics remain similar.
Time frame: 1 year
Correlation between the percentage of hypoxic tumour volume and clinical outcome
Correlation between the percentage of hypoxic tumour volume and clinical outcome will be evaluated by means of hazard ratio obtained from Cox regression. A hazard ratio \> 1 (p\<0.05) will indicate that the hypoxic tumour volume increase from 13 weeks post chemoradiation therapy (CRT) and recurrence is associated with worst Overall Survival (OS) and Progression Free Survival (PFS).
Time frame: 1 year
Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome
Correlation between the percentage change of hypoxic tumour volume during treatment and clinical outcome will be evaluated by means of hazard ration obtained from Cox regression. A hazard ratio \> 1 (p\<0.05) will indicate that the increase in hypoxic tumour volume during treatment is associated with worse OS.
Time frame: 1 year
Plan to share: Yes — After study completion, de-identified (non-coded, non-re-identifiable) data will be available to researchers for further scientific research. Information about data sharing will be provided to study participants in the Patient Information Sheet.
Supporting information: Study protocol, Icf
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University of Sydney