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Search / Trial NCT05763615

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 28, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

3 D Modeling Of The Cervico Facial Region Tractography Mri Diffusion Tensor Magnetic Resonance Imaging (Dt Mri) Cranial Nerve Pediatrics

ClinConnect Summary

The IMAG 2 ORL Project is a clinical trial focused on improving how doctors plan surgeries for children with head and neck tumors or congenital abnormalities (birth defects) in the face and neck. The study uses advanced 3D imaging techniques to create detailed models of the area where these tumors and abnormalities are located, helping to track important nerve fibers that could be affected during surgery. By doing this, the researchers aim to make surgeries safer and more effective for young patients.

To participate, children aged 1 to 5 who are undergoing a special type of MRI scan (called a 3T MRI) at Necker Enfants-Malades hospital may be eligible. This includes children with tumors or facial malformations, as well as a control group of children with different ear, nose, or throat issues. A signed consent form from a parent or guardian is required, and children with certain medical conditions that prevent them from having an MRI will not be included in the study. Participants can expect to undergo an MRI scan as part of the trial, contributing to a better understanding of how to manage these complex medical conditions in the future.

Gender

ALL

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.

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Romain Luscan, MD

Principal Investigator

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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