Hôpital Necker Enfants Malades
Paris, 75015, France
Location status: Recruiting
Location contact
Gael PLASTOW
CONTACT
Thomas BLANC, MD
CONTACT
NCT Number: NCT06418243
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.
Interested in participating?
Request Info3 month–17 year
All sexes
Observational
Paris, 75015, France
Location status: Recruiting
Gael PLASTOW
CONTACT
Thomas BLANC, MD
CONTACT
The investigator will inform the child and his parents during the pre-surgical consultation, and will collect their non-opposition to be included in the study at the latest on the day of the MRI examination or CT scan. Patients requiring emergency imaging will not be included.
Pelvic tumors will benefit from MRI imaging and renal tumors from MRI and/or CT scan.
A CT scan will be carried out for retroperitoneal tumors other than renal tumors (mainly neuroblastomas).
All of the above examinations are carried out as part of the usual treatment, in the month preceding the surgery.
Pre-operatively After the imaging has been carried out, the 2D images will be presented to the patient and his family before surgery as it is done routinely. The 3D image will be showed afterwards. The family will have the opportunity to ask questions which the surgeon will answer as usually done.
The specific questionnaire will be completed by the patient and his family at the end of the consultation and given to the research team.
Once the patient is included and the examinations have been carried out, the operating surgeons and their assistants (help No. 1 and 2) will look at the 2D images, followed by the 3D images secondly a few days before surgery. They will complete the specific questionnaire and give it to the research team.
Once the patient is included and the imaging examinations have been carried out, surgeons external to the service will be contacted by the research team to organize a remote review session. The 2D images will be presented to them first, followed by the 3D images on the visualization software, via a remote communication system with screen sharing. They will complete the specific questionnaire independently and a copy of the questionnaires will then be sent to the research team by email and the originals sent by post.
Intraoperatively:
The 3D model of the patient will be displayed in the operating room, and/or integrated into the robot's display console (for robot-assisted surgeries) during the surgical procedure. At the end of the surgery, the operating surgeon and his assistants will complete (independently) a questionnaire on the consistency of the 2D and 3D images with the anatomy identified during the procedure and on the help or not provided by the 3D model.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Children:
Other participants:
Exclusion criteria
Children :
Time frame: 1 month
Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index
Time frame: 1 month
Distance comparison between the reference segmentation and the one obtained by the algorithm using the Hausdorff spacing.
Time frame: Day 0
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 0
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 0
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 0
Surgeons' support evaluation for integrating 3D modelling into routine pre-operative planning from score 6 of the pre-operative questionnaire for operating or external surgeons
Time frame: Day 0
Evaluation of the contribution of 3D modelling for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively from score 1 of the family questionnaire
Time frame: Day 0
Evaluation of the contribution of 3D modelling for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively from score 2 of the family questionnaire
Time frame: Day 0
Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively from score 3 of the family questionnaire
Time frame: 1 month
Contribution of 3D modelling evaluation compared to 2D imaging for surgeons during surgery from score 1 of the post-operative questionnaire for operating surgeons and their helpers
Time frame: 1 month
Consistency evaluation of the 3D imaging with anatomy observed intraoperatively from score 2 of the post-operative questionnaire for operating surgeons and their helpers
Time frame: 1 month
Surgeons' support evaluation for integrating 3D modeling into their current practice from score 3 of the post-operative questionnaire for operating surgeons and their helpers
Contact information is provided by the study sponsor or research team.
Gael PLASTOW
CONTACT
Thomas BLANC, MD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
Acronym: 3D-PEDSURG
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.
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