Computational Anatomy in Surgery for Childhood Tumours and Malformations

NCT06224985 | Completed

• 1 other identifier: IMAG 2
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malformation; Tumor; Paediatric Surgery; 3D Imaging

Outcome Measures

Primary Outcomes (1)

• Images produced by General Electrics' 3 Tesla MRI

  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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (3)

Malformation

Tumors

Controls

Eligibility Criteria

• Age: 5 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in the three groups are followed in the visceral surgery department of Necker-Enfants Malades Hospital in Paris (France) for whose an MRI is required as part of diagnosis, extension assessment or monitoring.

You may qualify if:

• Patients
• Patient with a contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical cardiac valve, old vascular clips on cerebral aneurysm, etc.
• Controls :
• Patient with a contraindication to MRI: ocular metallic foreign body, pacemaker, cardiac mechanical valve, old vascular clips on cerebral aneurysm, etc.

Sponsors & Collaborators

• Imagine Institute: lead

Study Sites (1)

Necker enfants malades Hospital

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

Location

MeSH Terms

Conditions

Congenital Abnormalities; Neoplasms

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 25, 2024
• Study Start: April 16, 2016
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

FR (1)