Clinical trial · Interventional
Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No recrutment
Summary
Brief summary (as posted)
The objective of this study is to evaluate to what extent the capacity of the NODDI model can allow, in case of Malignant brain tumor patients with vasogenic edema, the elaboration of a reliable cerebral functional mapping in accordance with the data of direct electrical stimulation (DES) which is today the reference tool. the patient's participation in this study implies an additional visit during which an MRI examination without injection of contrast medium will be performed, lasting approximately 40 minutes (including installation and de-installation).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Brain Tumor | Malignant Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NODDI TRACT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NODDI TRACT
- description
- * Diffusion MRI (tractography) Tractography is performed on the basis of a diffusion MRI sequence which, after computer processing, will result in a map of the apparent diffusion coefficient and a diffusion tensor beam reconstruction (DTI tractography) performed with the Sisyphus software. * Multi-shell diffusion MRI (NODDI-tract)
- interventionNames
- Other: NODDI TRACT
Primary outcomes (1)
- measure
- Response to electrical stimulation
- timeFrame
- Hour 24
- description
- Response to electrical stimulation, which determines the presence or absence of an essential bundle, is the primary end point. The ability of the NODDI-tract method to reconstruct essential bundles in vasogenic edema will be assessed by estimating the correspondence between the response to intraoperative direct electrical stimulation (DES) and the presence of an MRI reconstructed bundle. Based on the response to electrical stimulation, the NODDI-tract data will be classified into one of four groups: * True positive = response to stimulation and presence of an MRI beam * True negative = no response to stimulation and no beam on MRI * False positive = no response to stimulation and presence of a beam on MRI * False-negative = response to stimulation and absence of beam in MRI. The distance between the reconstructed beam and the stimulation point (whether or not the stimulation was effective) will also be measured.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient 18 years of age or older, * Patient who has read and signed the consent form for participation in the study * Patient requiring surgery for a malignant brain tumor with vasogenic edema * Patient with an estimated life expectancy of more than 3 months. Exclusion Criteria: * Patient under legal protection, guardianship or trusteeship * Patient not affiliated to the French social security system * Contraindication to MRI (patient with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patient with hemostatic clips on intracerebral aneurysms or with orthopedic implants, claustrophobic patient) * Psychiatric history * Refusal to be informed of an abnormality detected during the MRI * Pregnant or breastfeeding woman
References
Publications (0)
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