Clinical trial · Interventional
3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project
NCT05763615CI-TRIAL-00101946IMAG 2 ORLcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Abnormalities | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tractography MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients
- description
- 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.
- interventionNames
- Other: Tractography MRI
- type
- EXPERIMENTAL
- label
- Control patients
- description
- 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.
- interventionNames
- Other: Tractography MRI
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 5 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDBasser 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
- BACKGROUNDBeaulieu 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
- BACKGROUNDJacquesson 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
- BACKGROUNDYoshino 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
- BACKGROUNDJacquesson 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
- BACKGROUNDMuller 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