PRaM-GBM
Research type
Research Study
Full title
Predicting sites of tumour progression in the invasive margin of glioblastomas (PRaM-GBM study)
IRAS ID
192258
Contact name
Stephen Price
Contact email
Sponsor organisation
Cambridge University Hospitals and the University of Cambridge
Duration of Study in the UK
2 years, 3 months, 31 days
Research summary
Brain tumours are the leading cause of cancer deaths in children, men under the age of 45 and women under the age of 25. The predominant treatment is surgical removal of the tumour followed by radiotherapy. Sadly the majority of patients given this treatment develop recurrent and progressive disease.
Better understanding of the invasive margin might improve outcomes by facilitating more complete surgical resection beyond the traditional contrast enhancing margins. Diffusion tensor MRI (DTI) is an imaging technique which may be able to predict the site of tumour recurrence.
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.
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This study will be conducted in 6-10 NHS centres, where 120 patients will be recruited, patients who are withdrawn will be replaced.
REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0476
Date of REC Opinion
9 Dec 2016
REC opinion
Further Information Favourable Opinion