Clinical trial · Interventional
Non Invasive Detection of IDH1/2 Mutation in Gliomas
Non Invasive IDentification of Gliomas With IDH1/2 Mutation by Analysis of Circulating Plasmatic DNA, D-2-hydroxyglutarate Dosage in Biological Liquids and Detection by Brain SPEctro-MRI: Impact for Diagnosis and Follow-up
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial develops a non invasive diagnostic approach of IDH1 mutated gliomas combining mutation detection from free plasmatic DNA, D-2HG dosage in urine samples, and D-2HG detection by Brain Spectro MRI. In group 1 (25 patients), patients with presumed grade II-III gliomas candidate to surgery will undergo spectro MRI, plasma, urine dosages. Results will then be confronted to tumor mutational status and D-2HG. In group 2 (15 patients), patients with known IDH1 mutation will undergo spectro MRI, plasma, urine dosages overtime in order to correlate results with the response to treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| IDH1/IDH2 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dosage of D-2HG in the urine | Other | — | UNRESOLVED |
| Dosage of free circulating plasmatic DNA | Other | — | UNRESOLVED |
| Spectro-MRI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IDH1/IDH2
- interventionNames
- Radiation: Spectro-MRI
- Other: Dosage of free circulating plasmatic DNA
- Other: Dosage of D-2HG in the urine
Primary outcomes (1)
- measure
- D-2HG quantified by spectroMRI the measure of the ratio between two pics D-2HG and creatine [Time Frame: 3 months after surgery] [Designated as safety issue: No]
- timeFrame
- 3 months after surgery
- description
- This ratio D-2HG/creatine will be correlated with the dosage obtained in tumor tissue performed within three months after the surgery
Secondary outcomes (1)
- measure
- SpectroMRI [Time Frame: evolution over 12 months] [Designated as safety issue: No]
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Affiliation to a social security system 2. Patient≥ 18 years old 3. Written informed consent 4. One of the two situations: * presumed grade II-III glioma candidate to surgery (group 1) * IDH1/IDH2 mutated grade II-III gliomas, candidate to chemotherapy or radiotherapy treatment, or simple follow-up (group 2) 5. Evaluable tumoral mass min diameter \>2 cm (FLAIR) 6. PKPS \> 60 Exclusion criteria 1. Contra-indication to MRI 2. Patient unable to give an written Informed Consent 3. Patient under guardianship or deprived of freedom 4. For group 2: patient already included in group 1
References
Publications (0)
Data not yet available