3D modeling and nerve tracking for pediatric head and neck conditions
3D Modeling of the Cervico-facial Region and Cranial Nerve Tractography: IMAG 2 ORL Project
This study is testing a new way to use 3D imaging to help doctors better plan surgeries for young children with head and neck tumors or birth defects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 1 Year to 5 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05763615 on ClinicalTrials.gov |
What this trial studies
This study focuses on using advanced 3D modeling and tractography MRI techniques to improve preoperative planning for children with head and neck tumors and congenital abnormalities. Children aged 1 to 5 who are undergoing a 3T MRI at the Necker Enfants-Malades hospital will participate in this study, which includes a validated tractography MRI sequence lasting 10 minutes. The aim is to accurately map cranial nerve pathways to enhance surgical management and outcomes for these patients. The study leverages mathematical algorithms to visualize nerve fiber paths based on the diffusion of water molecules in tissues.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 5 undergoing a 3T MRI for assessment of tumors or cervico-facial malformations.
Not a fit: Patients with contraindications to MRI or those not meeting the age and condition criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes for children with complex head and neck conditions.
How similar studies have performed: While the use of tractography MRI is established in other specialties, this specific application in pediatric ENT is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Paris
- Hôpital Necker-Enfants Malades — Paris, France (Recruiting)
Study contacts
- Principal investigator: Romain Luscan, MD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Romain Luscan, MD
- Email: romain.luscan@aphp.fr
- Phone: 1 71 39 66 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.