An interventional study of NODDI TRACT in Malignant Brain Tumor, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
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).
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
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Exclusion Criteria:
* 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
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.
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.
Time frame: Hour 24
Number of reconstructed fibers
Reconstructions obtained using the NODDI protocol or tractography will be compared on the total number of fibers reconstructed by both methods. The comparison will be made on the total number of reconstructed fibers and on the number of reconstructed fibers crossing the edema.
Time frame: Hour 24
Average distance to a reference atlas
The comparison is based on the evaluation of the average distance between the skeleton of the NODDI-tract reconstructed beams and that of the JHU tractography atlas \[20\]. The distance will be calculated by projecting the reconstructed skeleton onto the atlas skeleton, and as a function of the length traveled on the parameterized curve representing the skeleton. This function will be averaged over the entire length of the skeleton. An average distance of less than 1cm will be considered as a match criterion.
Time frame: Hour 24
Plan to share: No
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This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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GCS Ramsay Santé pour l'Enseignement et la Recherche