Hôpital Necker-Enfants Malades
Paris, 75015, France
NCT Number: NCT05763615
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.
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Notify Me1 year–5 year
All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
Time frame: 24 months
Imagery analysis of tractography MRI and implementation of a tractography algorithm.
Time frame: At the operation
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.
Time frame: 24 months
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).
Time frame: 12 months
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.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: IMAG 2 ORL
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