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

NCT05763615 | Completed

• 2 other identifiers: APHP2300152020-A02279-30
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Implementation of a tractography algorithm

  Imagery analysis of tractography MRI and implementation of a tractography algorithm.

  24 months

Secondary Outcomes (3)

• Evaluate the correlation between the 3D modeling and the intraoperative findings

  At the operation

• Course of the cranial nerves in children

  24 months

• Assess the presence of post-treatment sequelae nerve lesions

  12 months

Study Arms (2)

Patients

EXPERIMENTAL

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

Control patients

EXPERIMENTAL

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

Interventions

Tractography MRI OTHER

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.

Control patients; Patients

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (6)

• 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.

  PMID: 11025519 BACKGROUND

• 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.

  PMID: 12489094 BACKGROUND

• 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.

  PMID: 30010992 BACKGROUND

• 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.

  PMID: 27070917 BACKGROUND

• 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.

  PMID: 30476219 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Romain Luscan, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: May 10, 2023
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)