Clinical trial NCT06224985: Computational Anatomy in Surgery for Childhood Tumours and Malformations
Official title: Computational Anatomy in Surgery for Childhood Tumours and Malformations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malformation
Tumor
Paediatric Surgery
3D Imaging
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 131
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Images produced by General Electrics' 3 Tesla MRI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Post-operative consequences of surgery and/or rehabilitation treatment in patients with abdomino-pelvic tumours or pelvic malformations.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker enfants malades Hospital
state: Ile De France
Study officials:
References: