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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05763615
Acronym
IMAG 2 ORL
Enrollment
7
Registered
2023-03-10
Start date
2023-05-10
Completion date
2024-05-04
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Abnormalities, Head and Neck Neoplasms

Keywords

3D modeling of the cervico-facial region, Tractography MRI, Diffusion tensor magnetic resonance imaging (DT-MRI), Cranial nerve, Pediatrics

Brief summary

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

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.

Interventions

OTHERTractography MRI

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Implementation of a tractography algorithm24 monthsImagery analysis of tractography MRI and implementation of a tractography algorithm.

Secondary

MeasureTime frameDescription
Evaluate the correlation between the 3D modeling and the intraoperative findingsAt the operationEvaluate 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.
Course of the cranial nerves in children24 monthsCompare 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).
Assess the presence of post-treatment sequelae nerve lesions12 monthsAssess 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORRomain Luscan, MD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026