Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics
Recruiting
Phase 3
Interventional Study
Glioma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 88 (estimated)
- Sponsor
- Central Hospital, Nancy, France · Other
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About This Trial
the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age between 18 and 75 years old
* WHO general condition ≤2
* Identification of a unifocal brain tumour at the initial diagnosis with no contrast in the MRI and suspected to be a LGG, with biopsy/surgery envisaged within 6 months of the PET scan
* MRI performed a maximum of 3 w…
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