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

NCT06418243 | Recruiting

• 2 other identifiers: APHP2306802023-A02070-45
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Tumor; Retroperitoneal Tumor

Keywords

Surgery; 3D-Imaging; MRI; CT Scan; Paediatric surgery; Tumor

Outcome Measures

Primary Outcomes (1)

• Segmentation comparison

  Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index

  1 month

Secondary Outcomes (11)

• Distance comparison

  1 month

• Anatomical structure recognition comparison

  Day 0

• Pre-operative planning contribution

  Day 0

• Added value evaluation

  Day 0

• Surgeons' support evaluation in pre-operative routine

  Day 0

Study Arms (1)

Children planned to get an MRI or CT scan

Children with a pelvic or retroperitoneal tumor requiring an MRI or CT scan for a possible surgical intervention

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Emergency situation

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Imagine Institute: collaborator
• Ligue contre le cancer, France: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Necker Enfants Malades

Paris, 75015, France

RECRUITING

Related Publications (10)

• Wake 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 BACKGROUND

• Talanki 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 BACKGROUND

• Ibrahim 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 BACKGROUND

• van 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 BACKGROUND

• Bertrand 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 BACKGROUND

• Simons 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 BACKGROUND

• Valls-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.

  PMID: 37238380 BACKGROUND

• Hampshire J, Dicken BJ, Uruththirakodeeswaran T, Punithakumar K, Noga M. Pediatric patient-specific three-dimensional virtual models for surgical decision making in resection of hepatic and retroperitoneal tumors. Int J Comput Assist Radiol Surg. 2023 Oct;18(10):1941-1949. doi: 10.1007/s11548-023-02852-y. Epub 2023 Mar 11.

  PMID: 36905500 BACKGROUND

• Bernhard JC, Isotani S, Matsugasumi T, Duddalwar V, Hung AJ, Suer E, Baco E, Satkunasivam R, Djaladat H, Metcalfe C, Hu B, Wong K, Park D, Nguyen M, Hwang D, Bazargani ST, de Castro Abreu AL, Aron M, Ukimura O, Gill IS. Personalized 3D printed model of kidney and tumor anatomy: a useful tool for patient education. World J Urol. 2016 Mar;34(3):337-45. doi: 10.1007/s00345-015-1632-2. Epub 2015 Jul 11.

  PMID: 26162845 BACKGROUND

• Youn JK, Park SJ, Choi YH, Han JW, Ko D, Byun J, Yang HB, Kim HY. Application of 3D printing technology for pre-operative evaluation, education and informed consent in pediatric retroperitoneal tumors. Sci Rep. 2023 Jan 30;13(1):1671. doi: 10.1038/s41598-023-28423-4.

  PMID: 36717595 BACKGROUND

MeSH Terms

Conditions

Pelvic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Sabine SARNACKI, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Central Study Contacts

Thomas BLANC, MD

CONTACT

+33 1 44 49 41 53; thomas.blanc@aphp.fr

Gael PLASTOW

CONTACT

+33 1 44 38 18 57; gael.plastow@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)