Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery

NCT ID: NCT05669326

Last Updated: 2025-12-03

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-09-01

Brief Summary

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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).

Detailed Description

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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

Conditions

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Malignant Brain Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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)

Group Type EXPERIMENTAL

NODDI TRACT

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique de l'Union

Saint-Jean, , France

Site Status

Countries

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France

Other Identifiers

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2021-A02074-37

Identifier Type: -

Identifier Source: org_study_id

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