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Evaluation of diagnostic performances of 18F-FDOPA PET KInetics as biomarkers for the improvement of care of MRI Non-contrast enhanced Gliomas : a phase IIIb exploratory trial
EU CTIS ID: 2022-501688-42-00
What this study is testing
To assess diagnostic performances of 18F-FDOPA PET Time-To-Peak (TPP) in suspected LGGs without MRI -contrast enhancement for characterisation of aggressive lesions defined as high histopathological grade (3 or 4) or dismal molecular characteristics (CDKN2A/B deletion in IDH-mutant astrocytomas, molecular features of glioblastoma in IDH-wildtype gliomas) by the pathology analyses performed within 6 months post-inclusion.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 and 75 years old
- WHO general condition ≤2
- Identification of an 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/CT
- MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
- Subject affiliated to or beneficiary of a social security plan
- Subject having received complete information on the organisation of the research and having signed the informed consent form.
You likely can't join if
- Multifocal brain lesions
- Contraindication to 18F-FDOPA PET
- Concomitant treatment by Carbidopa, Halopéridol, Réserpine and MAOIs.
- Pregnant, parturient women or nursing mothers under Article L1121-5
- Women of childbearing age who do not have effective contraception under Article L1121-5
- Monitoring not possible
See the full eligibility criteria
- Age between 18 and 75 years old
- WHO general condition ≤2
- Identification of an 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/CT
- MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of contrast agent and T2 FLAIR).
- Subject affiliated to or beneficiary of a social security plan
- Subject having received complete information on the organisation of the research and having signed the informed consent form.
- Multifocal brain lesions
- Contraindication to 18F-FDOPA PET
- Concomitant treatment by Carbidopa, Halopéridol, Réserpine and MAOIs.
- Pregnant, parturient women or nursing mothers under Article L1121-5
- Women of childbearing age who do not have effective contraception under Article L1121-5
- Monitoring not possible
- Persons deprived of their liberty by a judicial or administrative decision under Article 1121-8, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.