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Trial Title:
3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project
NCT ID:
NCT05763615
Condition:
Head and Neck Neoplasms
Congenital Abnormalities
Conditions: Official terms:
Head and Neck Neoplasms
Congenital Abnormalities
Conditions: Keywords:
3D modeling of the cervico-facial region
Tractography MRI
Diffusion tensor magnetic resonance imaging (DT-MRI)
Cranial nerve
Pediatrics
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Tractography MRI
Description:
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.
Arm group label:
Control patients
Arm group label:
Patients
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.
Criteria for 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.
Gender:
All
Minimum age:
1 Year
Maximum age:
5 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Necker-Enfants Malades
Address:
City:
Paris
Zip:
75015
Country:
France
Status:
Recruiting
Contact:
Last name:
Romain Luscan, MD
Phone:
1 71 39 66 38
Phone ext:
+33
Email:
romain.luscan@aphp.fr
Investigator:
Last name:
Vincent Couloigner, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Nathalie Boddaert, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Raphaël Levy, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sabine Sarnacki, MD, PhD
Email:
Principal Investigator
Start date:
May 10, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05763615
