Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors

Recruiting

• Conditions: Pelvic Tumor; Retroperitoneal Tumor

• Registration Number: NCT06418243
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-13
• Study First Posted: 2024-05-17
• Study Start: 2024-09-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Children:

• 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
• Children whose parents do not object to their participation in the study

Other participants:

• Operating surgeon agreeing to participate in the study
• Caregiver agreeing to participate in the study
• External surgeon agreeing to participate in the study

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Exclusion Criteria

Children :

• 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
• Emergency situation

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Segmentation comparison	1 month	Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index

Secondary Outcome Measures

Name	Time	Method
Distance comparison	1 month	Distance comparison between the reference segmentation and the one obtained by the algorithm using the Hausdorff spacing.
Anatomical structure recognition comparison	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
2D imaging evaluation contribution for families' understanding	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
3D modelling added value evaluation pre-operatively	Day 0	Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively from score 3 of the family questionnaire
Consistency evaluation between 3D modelling and anatomy	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
Pre-operative planning contribution	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
3D modelling evaluation contribution for families' understanding	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
Added value evaluation	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
Surgeons' support evaluation in pre-operative routine	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
3D modelling added value evaluation during surgery	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
Surgeons' support evaluation in current practice	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

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades; 🇫🇷 Paris, France