Clinical trial · Observational
MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy
Magnetic Resonance Imaging of Hypoxia for Radiation Treatment Guidance in Glioblastoma Multiforme (MANGO)
NCT05500612CI-TRIAL-00111994MANGOrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determination of spatial correlation of hypoxic tumour volume between Magnetic resonance imaging (MRI) and [18F]-Fluoromisonidazole (18F-FMISO) MRI
- timeFrame
- 1 year
- description
- 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.
Secondary outcomes (4)
- measure
- Repeatability of voxel-wise levels of hypoxia in the tumour
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected high-grade glioma (HGG) / glioblastoma multiforme (WHO grade IV) at initial radiological examination * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 * Available for scanning on two separate days Exclusion Criteria: * Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study * Patients with a history of severe renal disease(s) (eGFR \<20) that cannot tolerate gadolinium chelate contrast agents. * Geographically remote patients unable to agree to imaging schedule * Patients who have received anti - vascular endothelial growth factor (anti-VEGF) monoclonal antibody therapy the 3 months prior to recruitment * Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. * Patients with significant cardiac or pulmonary disease including cardiac arrythmias or Chronic Obstructive Pulmonary Disease (COPD) that are unable to tolerate high flow O2 for oxygen contrast. * Patients taking carbonic anhydrase inhibitors (Acetazolamide) * History of glaucoma * Any implant, foreign body, 3 Tesla (3T) MRI incompatible device, or other contraindication to MRI imaging.
References
Publications (0)
Data not yet available
No reference posted for this study.