Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-17
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
This study's purpose is the comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index. It is implemented by making parents' patients, surgeons and surgical helpers answer specific questions comparing 3D images to usual 2D images of the patient's tumor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children between 3 months and less than 18 years old
Children with a pelvic tumor requiring an MRI for a possible surgical intervention
Children with a retroperitoneal tumor requiring a CT scan or MRI with a view to surgical intervention
Children with no contraindication for a CT scan and/or 3T MRI
Disqualifiers
Contraindication to MRI: metallic ocular foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm
Need for an MRI under general anaesthesia
Contraindication for a CT scan with injection: renal failure, allergy to iodinated contrast products
Patients having participated in a therapeutic clinical trial involving a new molecule within 30 days before inclusion
Trial population
Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention coming at the hospital for a consultation as part of their standard care.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Children planned to get an MRI or CT scan
Trial outcomes
Primary outcomes
1
Segmentation comparison
Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index
Time frame
1 monthSecondary outcomes
1
Distance comparison
Distance comparison between the reference segmentation and the one obtained by the algorithm using the Hausdorff spacing.
Time frame
1 month2
Anatomical structure recognition comparison
Recognition of anatomical structures comparison from 2D imaging and 3D imaging from score 1/score 3 of the pré-operative questionnaire for operating or external surgeons
Time frame
Day 03
Pre-operative planning contribution
Contribution of 3D modeling comparison to 2D imaging in pre-operative planning from score 2/score 4 of the pre-operative questionnaire for operating or external surgeons
Time frame
Day 04
Added value evaluation
Added value evaluation of 3D modelling compared to 2D imaging by using score 5 of the pre-operative questionnaire for operating or external surgeons
Time frame
Day 0Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Imagine Institute
Collaborator
Ligue contre le cancer, France
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov