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

Last updated: August 12, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Holoprosencephaly

Birth Defects

Treatment

Tractography MRI

Clinical Study ID

NCT05763615
APHP230015
2020-A02279-30
  • Ages 1-5
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 NeckerEnfants-Malades hospital as part of the initial assessment of a tumor or acervico-facial malformation.

  • Control group: children aged 1 to 5 benefiting from a 3T MRI at the NeckerEnfants-Malades hospital as part of the initial assessment of an ENT pathology otherthan that of the patient group (examples: velar insufficiency, congenital deafness).

Exclusion

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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Tractography MRI
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Hôpital Necker-Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

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