NCT05669326

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Malignant Brain Tumor

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2022-12-30
• Last updated: 2025-12-03

Locations

1 site across 1 country: France