NCT00628940CompletedPhase 1
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University Ghent
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- time to local recurrence after neurosurgery and adjuvant radiochemotherapy
Study Overview
Brief Summary
The aim of the study is to define preferential sites of tumour recurrence by observing tracer uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR, see also below). Changes in the intensity of the tracer uptake in the tumour during and after the course of radiotherapy will be correlated with the site of tumour recurrence as will be assessed by conventional MRI. In due time, these results must enable clinicians to change their therapeutic approach of high-grade glioma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery
Exclusion Criteria
- •low global performance state
- •pregnancy
- •lactation period
- •presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips
Arms & Interventions
1
Experimental
18F-fluoromethylcholine
Intervention: PET images with 18F-fluoromethylcholine (Radiation)
Outcomes
Primary Outcomes
time to local recurrence after neurosurgery and adjuvant radiochemotherapy
Time Frame: 18 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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