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

Head and Neck Neoplasms Clinical Trial

— IMAG 2 ORL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763615
• Other study ID #: APHP230015
• Secondary ID: 2020-A02279-30
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: May 2025

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Romain Luscan, MD
• Phone: 1 71 39 66 38
• Email: romain.luscan[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Head and Neck Neoplasms

Intervention

Other:
• Tractography 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.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation of a tractography algorithm	Imagery analysis of tractography MRI and implementation of a tractography algorithm.	24 months
Secondary	Evaluate the correlation between the 3D modeling and the intraoperative findings	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.	At the operation
Secondary	Course of the cranial nerves in children	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).	24 months
Secondary	Assess the presence of post-treatment sequelae nerve lesions	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.	12 months