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

NCT03294434 | Completed

• 1 other identifier: PRaM-GBM
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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. Glioblastoma is the most common and most malignant primary tumour. 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. DTI has previously been shown to identify regions, which have been confirmed with biopsies, to be areas of invasive tumours and are present before progression is seen with an MRI. The primary aim of this study is to qualify an imaging biomarker that can be applied at initial presentation, that can accurately predict the site of where glioblastomas will progress after treatment and allow personalisation of both radiotherapy and surgical targets.

Conditions

High Grade Glioma

Outcome Measures

Primary Outcomes (1)

• Site of glioblastoma true progression correctly predicted by DTI scan

  Assess the diagnostic accuracy of DTI at pre-surgery or/and pre-radiotherapy as a biomarker to predict site of glioblastoma progression

  18 months

Secondary Outcomes (5)

• Accuracy of DTI as a biomarker

  18 months

• Perfusion imaging

  18 months

• Time to progression

  18 months

• Extent of resection and volume of tumour that remains post-surgery by standard imaging and DTI

  18 months

• Radiotherapy dose according to DTI-defined invasive region

  18 months

Other Outcomes (3)

• Difference of area highlighted by amino-acid PET and DTI-MRI

  18 months

• Number of amino-acid PET only image guided biopsies taken from patients

  18 months

• Site of glioblastoma true progression correctly predicted from pre-operative imaging by a region that is predicted by the DTI abnormality outside of the area of increased uptake to amino-acid on PET

  18 months

Study Arms (1)

High Grade Glioma

Diffusion tensor Imaging (DTI-MRI) scan to be performed pre-operatively and pre-radiotherapy

Other: Diffusion tensor Imaging (DTI)

Interventions

Diffusion tensor Imaging (DTI) OTHER

Diffusion tensor Imaging (DTI) is a technique sensitive to the ordered diffusion of water along white matter tracts and can detect subtle disruption. A diffusion tensor signature method was developed that splits the tensor information into isotropic and anisotropic diffusion components. This can differentiate regions of pure tumour from invaded white matter.

High Grade Glioma

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients aged 16 and over with newly diagnosed glioblastomas

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• CCTU- Cancer Theme: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Cancer Research UK: collaborator
• Experimental Cancer Medicine Centres: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients that consent to participate in the optional PET sub-study will consent to the collection of additional tissue biopsies to be taken at the time of their standard of care surgery.

MeSH Terms

Conditions

Glioma

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Stephen Price

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CCTU-Cancer Theme

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: September 27, 2017
• Study Start: March 2, 2017
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)