Computational Anatomy in Surgery for Childhood Tumours and Malformations

This study is part of the launch of a multidisciplinary project called IMAG2, for image-guided minimally invasive surgery. It involves collaboration between the radiology and surgery teams at Necker Hospital and the Image Processing and Interpretation (TII) team at the LTCI at Télécom ParisTech.

To make a decision, surgeons need access to a 3D model reflecting the anatomy of the specific patient and its pathological variations. Patient-specific 3D reconstruction provides a significant improvement, leading to a precise assessment of the malformation or tumour and its relationship with surrounding organs, nerves and vessels. It allows the surgeon to simulate a pre-operative procedure, which is a definite advantage in terms of safe, effective and curative surgery, particularly in oncology. MRI has been chosen as the basic imaging technique because of its non-irradiating nature and the current lack of 3D MRI reconstruction technology.

The study aims to provide an aid to diagnosis and surgical planning by developing dedicated methods and algorithms for segmenting not only the tumour but also the main anatomical components surrounding the tumour from 3D MRI imaging data. The imaging will be performed on a 3 Tesla MRI. The data will be that required for diagnosis and surgical planning, acquired on a routine clinical basis with an expected benefit for patients.

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Key information

Conditions

Malformation 3D Imaging Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neoplasms Paediatric Surgery Tumor

Age range

5 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Necker enfants malades Hospital

Paris, Île-de-France Region, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be included, patients must meet the following criteria:

Patient aged between 5 months and 17 years
Patient with a confirmed diagnosis of :

Abdomino-pelvic tumour
Pelvic malformation
Patient whose parents or legal guardians have read, accepted and signed the study consent form
Patients whose parents or legal guardians are beneficiaries of a social security scheme.

To be included, control patients (patients other than those suffering from an abdomino-pelvic tumour or malformation) must meet the following criteria:

Patient aged between 5 months and 17 years inclusive.
A patient being followed in the visceral surgery department for a pathology other than tumour or malformation, and requiring MRI as part of his or her diagnosis, extension assessment or monitoring.
Patient whose parents or legal guardians have read, accepted and signed the study consent form.
Patient whose parents or guardians are beneficiaries of a social security scheme.

Non inclusion criteria :

Patients

Patient with a contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical cardiac valve, old vascular clips on cerebral aneurysm, etc.
Patient having participated in a therapeutic clinical trial involving a new molecule in the 30 days prior to inclusion.

Controls :

Patient with a contraindication to MRI: ocular metallic foreign body, pacemaker, cardiac mechanical valve, old vascular clips on cerebral aneurysm, etc.
Patient having participated in a therapeutic clinical trial involving a new molecule in the 30 days prior to inclusion.

Treatment and study plan

Primary outcomes

Images produced by General Electrics' 3 Tesla MRI

Time frame: through study completion, an average of 1 year

Nerve network in areas of interest (pelvis) using tractography analysis with 3 Tesla MRI by automation of 3D imaging using images produced by General Electrics' 3 Tesla MRI. This automation will be carried out using software developed by Telecom Paristech.

Secondary outcomes

Post-operative consequences of surgery and/or rehabilitation treatment in patients with abdomino-pelvic tumours or pelvic malformations.

Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: IMAG2

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Jan 25, 2024
Registry last updated: Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed