NCT03294434Completed
Predicting Sites of Tumour Progression in the Invasive Margin of Glioblastomas (PRaM-GBM Study)
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 147 (actual)
- First submitted
- 22 Sept 2017
- Start date
- 2 Mar 2017
- Primary completion date
- 11 Jul 2024
- Lead sponsor
- CCTU- Cancer Theme
- Diseases
- Glioblastoma, Childhood cancers
- NCT number
- NCT03294434
What you commit to
- Study type: Observational
- Participants enrolled: 147
- From 2 Mar 2017 to the primary completion date, 11 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MR unsafe metallic implants;
Other illness
- Allergy to gadolinium contrast agent;
- History of severe renal impairment.
Other
- 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:
- Claustrophobia;
- Patients unable to provide written informed consent
- PET sub-study only: Pregnant women
Who the study is looking for
- 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;
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.