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

Primary Purpose

Malignant Brain Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NODDI TRACT
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinique de l'Union

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NODDI TRACT

Arm 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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 20, 2022
Last Updated
December 20, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05669326
Brief Title
Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
Acronym
NODDI-TRACT
Official Title
Evaluation of the Contribution of NODDI Protocol Tractography in Brain Tumor Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Brain Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NODDI TRACT
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
NODDI TRACT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response to electrical stimulation
Description
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
Secondary Outcome Measure Information:
Title
Number of reconstructed fibers
Description
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
Title
Average distance to a reference atlas
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Clinique de l'Union
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent LUBRANO, MD
Phone
05 61 37 81 81
Ext
33
Email
vincentlubrano@gmail.com
First Name & Middle Initial & Last Name & Degree
Vincent LUBRANO, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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