Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery (NODDI-TRACT)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Withdrawn

Conditions: Malignant Brain Tumor

Treatments: Other: NODDI TRACT

Study type: Interventional

Funder types: Other

Identifiers

NCT05669326

2021-A02074-37

Details and patient eligibility

About

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).

Full description

This is a single-center, prospective, open-label study of neurosurgical patients.

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

NODDI TRACT

Experimental group

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)

Treatment:

Other: NODDI TRACT