3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project

Study Overview
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Brief Summary
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3D modeling associated with the tracking of nerve fibers meets the needs of preoperative planning for tumors and cervico-facial congenital malformations. Indeed, these lesions are closely related to the cranial nerves and in particular nerve V (infratemporal fossa), nerve VII (temporal bone, parotido-masseter region), nerves IX, X, XI, XII and the chain cervical sympathetic (infratemporal and cervical regions). The development of a model of this region will therefore improve the surgical management of these children.

Detailed Description
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Children aged 1 to 5 benefiting from a 3T magnetic resonance imaging (MRI) at the Necker Enfants-Malades hospital for their care, meeting the inclusion criteria and participating in the study, will benefit during their MRI from the care, a sequence Research tractography MRI lasting 10 minutes. This sequence is already validated and proposed for tractography but in specialties other than pediatric ENT. Tractography techniques are mathematical algorithms based on the diffusion tensor (micro-movements of water molecules in tissues) to reconstruct the path of nerve fibers in each volume unit of the MRI image (voxel). 3D modeling associated with the tracking of nerve fibers meets the needs of preoperative planning for tumors and cervico-facial congenital malformations. Indeed, these lesions are closely related to the cranial nerves.

Official Title
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3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project

Conditions
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Head and Neck Neoplasms, Congenital Abnormalities

Intervention / Treatment
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* Other: Tractography MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Benefiting from social security scheme. Informed consent signed by holders of parental authority and the investigator. Patient group: children aged 1 to 5 benefiting from a 3T MRI at the Necker Enfants-Malades hospital as part of the initial assessment of a tumor or a cervico-facial malformation. Control group: children aged 1 to 5 benefiting from a 3T MRI at the Necker Enfants-Malades hospital as part of the initial assessment of an ENT pathology other than that of the patient group (examples: velar insufficiency, congenital deafness). Exclusion Criteria: Child with a contraindication to MRI: allergy to contrast product, pacemaker, Starr Edwards valves, stent placed for less than 6 weeks, vascular clips, contraindication to sedation.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Children aged 1 to 5 benefiting from a 3T MRI at the Necker Enfants-Malades hospital as part of the initial assessment of a tumor or cervico-facial malformation and at the first postoperative follow-up MRI if indicated for the care during a period of 12 months. | Other: Tractography MRI<br>* Addition to the sequences usually done for the care of these patients (CubeT2, Diffusion, CubeT1, CubeT2 fiesta, ASL, T1 injected with gadolinium), of a so-called research tractography sequence benefiting from CE marking and not requiring specific injection. Search sequence acquisition time: 10 minutes.<br>|
| Experimental: Control patients<br>Children aged 1 to 5 benefiting from a 3T MRI at the Necker Enfants-Malades hospital as part of the initial assessment of an ENT pathology other than that of the patient group. | Other: Tractography MRI<br>* Addition to the sequences usually done for the care of these patients (CubeT2, Diffusion, CubeT1, CubeT2 fiesta, ASL, T1 injected with gadolinium), of a so-called research tractography sequence benefiting from CE marking and not requiring specific injection. Search sequence acquisition time: 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation of a tractography algorithm | Imagery analysis of tractography MRI and implementation of a tractography algorithm. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the correlation between the 3D modeling and the intraoperative findings | Evaluate the correlation between the 3D modeling and the intraoperative findings. Intraoperative evaluation of the position of the facial nerve and its relationship to the tumor. | At the operation | 
| Course of the cranial nerves in children | Compare the course of the cranial nerves in children treated for tumor or congenital malformation compared to control patients treated for another ENT pathology: comparison of images obtained between patients and controls (radiological analysis). | 24 months | 
| Assess the presence of post-treatment sequelae nerve lesions | Assess the presence of post-treatment sequelae nerve lesions for subject patients (surgery or radiochemotherapy) on follow-up MRI: during follow-up MRIs, analysis by tractography of the nerve related to the lesion. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D modeling of the cervico-facial region, Tractography MRI, Diffusion tensor magnetic resonance imaging (DT-MRI), Cranial nerve, Pediatrics