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

NCT05669326 | Withdrawn

• 1 other identifier: 2021-A02074-37
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Malignant Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Response to electrical stimulation

  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.

  Hour 24

Secondary Outcomes (2)

• Number of reconstructed fibers

  Hour 24

• Average distance to a reference atlas

  Hour 24

Study Arms (1)

NODDI TRACT

EXPERIMENTAL

* 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)

Other: NODDI TRACT

Interventions

NODDI TRACT 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.

NODDI TRACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: December 30, 2022
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)