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New treatment option for Glioma
Official title Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics
ClinicalTrials.gov ID: NCT05512403
What this study is testing
What is PET/CT with 18F-DOPA?
PET/CT with 18F-DOPA is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- MRI performed a maximum of 3 weeks before inclusion and comprising the conventional morphological sequences (T1, T1 sequences with injection of...
- Subject affiliated to or beneficiary of a social security plan
You likely can't join if
- Multifocal brain lesions
- Contraindication to 18F-FDOPA PET
- 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...
See the full eligibility 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 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
- 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.
- Patients cannot simultaneously participate in an treatment research trial for the duration of the KING study
The study team makes the final eligibility decision.
Where it's taking place
- Vandœuvre-lès-Nancy, France
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.