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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
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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