Predicting Sites of Tumour Progression in the Invasive Margin of Glioblastomas (PRaM-GBM Study)

This is a multicentre, prospective longitudinal observational cohort study in patients with high grade glioma, who have surgery planned to remove >90% of the tumour, and subsequent radical radiotherapy with concomitant tomozolomide. The purpose of this study is to establish a model using DTI that can accurately predict the site of where glioblastomas will progress after treatment. This study aims to validate the use of DTI as a biomarker across multiple centres to develop analysis methods that could be used in the future to personalise radiotherapy treatment volumes, and potentially surgical targets.

Patients will be given a DTI-MRI both prior to the operation and prior to radiotherapy. Clinical MRIs will take place according to standard guidelines. Whilst the study is open patients will participate in the study until death. Once a total of 70 patients from the first 90 have shown true progression patients will participate in the study for a minimum of 6 months from the beginning of radiotherapy.

This study will be conducted in 6-10 NHS centres, where 120 patients will be recruited, patients who are withdrawn will be replaced.

Inclusion criteria

• Have given written informed consent to participate
• Assessed by a neuroscience MDT to have a high grade glioma on imaging, OR if in the opinion of the CI, with guidance from the local PI that all relevant and appropriate members of a multidisciplinary team agree a high grade glioma diagnosis;
• Considered suitable for radical radiotherapy (60 Gy) with concomitant chemotherapy (Stupp Regime);
• WHO PS 0 or 1 (see Appendix 3);
• Age ≥16;
• Patient suitable for tumour resection where the treating neurosurgeon feels that >90% of the enhancing tumour will be resected;

Exclusion criteria

• Patients who are participating in trials involving investigational treatments
• Patients who are unsuitable for a contrast-enhanced MRI will be excluded. Such clinical problems include, but are not limited to:
• MR unsafe metallic implants;
• Claustrophobia;
• Allergy to gadolinium contrast agent;
• History of severe renal impairment.
• Patients unable to provide written informed consent
• PET sub-study only: Pregnant women