Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
NCT ID: NCT05669326
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-09-01
2025-09-01
Brief Summary
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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).
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Detailed Description
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Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without injection of contrast product will be performed, lasting approximately 40 minutes (including installation and de-installation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NODDI TRACT
* 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)
NODDI TRACT
Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without contrast injection will be performed, lasting approximately 40 minutes (including installation and deinstallation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study.
Interventions
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NODDI TRACT
Compared to their usual management, the participation of the patient in this study implies an additional visit during which an MRI examination without contrast injection will be performed, lasting approximately 40 minutes (including installation and deinstallation).
The operative time, surgical procedures and postoperative follow-up are not modified in this study.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Clinique de l'Union
Saint-Jean, , France
Countries
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Other Identifiers
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2021-A02074-37
Identifier Type: -
Identifier Source: org_study_id
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