Clinical trial · Observational
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors
Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
NCT06418243CI-TRIAL-001062303D-PEDSURGrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pelvic Tumor | — | UNRESOLVED | — |
| Retroperitoneal Tumor | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Children planned to get an MRI or CT scan
- description
- Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention
Primary outcomes (1)
- measure
- Segmentation comparison
- timeFrame
- 1 month
- description
- Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index
Secondary outcomes (11)
- measure
- Distance comparison
- timeFrame
- 1 month
- description
- Distance comparison between the reference segmentation and the one obtained by the algorithm using the Hausdorff spacing.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 17 Years
Show eligibility criteria text
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 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
References
Publications (10)
- BACKGROUNDWake N, Wysock JS, Bjurlin MA, Chandarana H, Huang WC. "Pin the Tumor on the Kidney:" An Evaluation of How Surgeons Translate CT and MRI Data to 3D Models. Urology. 2019 Sep;131:255-261. doi: 10.1016/j.urology.2019.06.016. Epub 2019 Jun 22. PMID 31233814
- BACKGROUNDTalanki VR, Peng Q, Shamir SB, Baete SH, Duong TQ, Wake N. Three-Dimensional Printed Anatomic Models Derived From Magnetic Resonance Imaging Data: Current State and Image Acquisition Recommendations for Appropriate Clinical Scenarios. J Magn Reson Imaging. 2022 Apr;55(4):1060-1081. doi: 10.1002/jmri.27744. Epub 2021 May 27. PMID 34046959
- BACKGROUNDIbrahim I, Skoch A, Herynek V, Jiru F, Tintera J. Magnetic resonance tractography of the lumbosacral plexus: Step-by-step. Medicine (Baltimore). 2021 Feb 12;100(6):e24646. doi: 10.1097/MD.0000000000024646. PMID 33578590
- BACKGROUNDvan der Zee JM, Fitski M, Simonis FFJ, van de Ven CP, Klijn AJ, Wijnen MHWA, van der Steeg AFW. Virtual Resection: A New Tool for Preparing for Nephron-Sparing Surgery in Wilms Tumor Patients. Curr Oncol. 2022 Feb 1;29(2):777-784. doi: 10.3390/curroncol29020066. PMID 35200565
- BACKGROUNDBertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17. PMID 24838739
- BACKGROUNDSimons DC, Buser MAD, Fitski M, van de Ven CP, Ten Haken B, Wijnen MHWA, Tan CO, van der Steeg AFW. Multi-modal 3-Dimensional Visualization of Pediatric Neuroblastoma: Aiding Surgical Planning Beyond Anatomical Information. J Pediatr Surg. 2024 Aug;59(8):1575-1581. doi: 10.1016/j.jpedsurg.2024.02.025. Epub 2024 Feb 24. PMID 38461108
- BACKGROUNDValls-Esteve A, Adell-Gomez N, Pasten A, Barber I, Munuera J, Krauel L. Exploring the Potential of Three-Dimensional Imaging, Printing, and Modeling in Pediatric Surgical Oncology: A New Era of Precision Surgery. Children (Basel). 2023 May 3;10(5):832. doi: 10.3390/children10050832.