Status:
UNKNOWN
Functional and Ultrasound Guided Resection of Glioblastoma
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Efficacy and Mechanism Evaluation (EME) Programme
Conditions:
Glioma Glioblastoma Multiforme
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Functional and ultrasound-guided resection of glioblastoma: assessing the use of additional imaging during surgery to improve outcomes for patients with glioblastoma brain tumours
Detailed Description
Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery. Stage 2 will be randomised. Randomisation will be via the web-based ser...
Eligibility Criteria
Inclusion
- Age 18-70 years
- Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour)
- Patient is suitable for concomitant adjuvant radiotherapy and Temozolomide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision
- Able to receive 5-ALA
- Willing and able to give informed consent
- Able to complete trial questionnaires, this may be with support where English is not their first language. (Stage 2 only)
- Able to provide a proxy who is willing to complete questionnaires as requested (Stage 2 only).
Exclusion
- Midline/basal ganglia/cerebellum/brainstem GB
- Multifocal GB
- Recurrent GB
- Suspected secondary GB
- Contraindication to MRI
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT05399524
Start Date
November 1 2020
End Date
November 1 2025
Last Update
June 1 2022
Active Locations (24)
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1
Queen Elizabeth Hospital, University Hospitals Birmingham NHSFT
Birmingham, United Kingdom, B15 2TH
2
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
3
Southmead Hospital, North Bristol NHST
Bristol, United Kingdom, BS10 5NB
4
Addenbrookes Hospital, Cambridge University NHSFT
Cambridge, United Kingdom, CB2 0QQ