Clinical trial NCT05763615: 3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project
Official title: 3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Congenital Abnormalities
Keywords: 3D modeling of the cervico-facial region
Tractography MRI
Diffusion tensor magnetic resonance imaging (DT-MRI)
Cranial nerve
Pediatrics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implementation of a tractography algorithm
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate the correlation between the 3D modeling and the intraoperative findings
timeFrame: At the operation
measure: Course of the cranial nerves in children
timeFrame: 24 months
measure: Assess the presence of post-treatment sequelae nerve lesions
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Romain Luscan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basser PJ, Pajevic S, Pierpaoli C, Duda J, Aldroubi A. In vivo fiber tractography using DT-MRI data. Magn Reson Med. 2000 Oct;44(4):625-32. doi: 10.1002/1522-2594(200010)44:43.0.co;2-o.
citation: Beaulieu C. The basis of anisotropic water diffusion in the nervous system - a technical review. NMR Biomed. 2002 Nov-Dec;15(7-8):435-55. doi: 10.1002/nbm.782.
citation: Jacquesson T, Frindel C, Kocevar G, Berhouma M, Jouanneau E, Attye A, Cotton F. Overcoming Challenges of Cranial Nerve Tractography: A Targeted Review. Neurosurgery. 2019 Feb 1;84(2):313-325. doi: 10.1093/neuros/nyy229.
citation: Yoshino M, Abhinav K, Yeh FC, Panesar S, Fernandes D, Pathak S, Gardner PA, Fernandez-Miranda JC. Visualization of Cranial Nerves Using High-Definition Fiber Tractography. Neurosurgery. 2016 Jul;79(1):146-65. doi: 10.1227/NEU.0000000000001241.
citation: Jacquesson T, Cotton F, Attye A, Zaouche S, Tringali S, Bosc J, Robinson P, Jouanneau E, Frindel C. Probabilistic Tractography to Predict the Position of Cranial Nerves Displaced by Skull Base Tumors: Value for Surgical Strategy Through a Case Series of 62 Patients. Neurosurgery. 2019 Jul 1;85(1):E125-E136. doi: 10.1093/neuros/nyy538.
citation: Muller CO, Mille E, Virzi A, Marret J-B, Peyrot Q, Delmonte A, et al. Integrating tractography in pelvic surgery: a proof of concept. J Pediatr Surg Case Rep. 1 sept 2019;48:101268