## Protocol Section
### Identification Module
**NCT ID:** NCT06418243

**Acronym:** 3D-PEDSURG

**Brief Title:** Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors

**Official Title:** Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging

#### Organization Study ID Info
**ID:** APHP230680
#### Organization
**Class:** OTHER
**Full Name:** Assistance Publique - Hôpitaux de Paris
#### Secondary ID Infos
**Domain:** ID-RCB
**ID:** 2023-A02070-45
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Imagine Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** Assistance Publique - Hôpitaux de Paris

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pelvic Tumor

- Retroperitoneal Tumor

**Keywords:**

- Surgery

- 3D-Imaging

- MRI

- CT Scan

- Paediatric surgery

- Tumor

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Label:** Children planned to get an MRI or CT scan

### Outcomes Module

#### Primary Outcomes

**Description:** Comparison of the automatically segmented 3D model to the reference manual segmentation

**Measure:** Segmentation comparison

**Time Frame:** 1 month

#### Secondary Outcomes

**Description:** Distance comparison between the reference segmentation and the one obtained by the algorithm

**Measure:** Distance comparison

**Time Frame:** 1 month

**Description:** Recognition of anatomical structures comparison from 2D imaging and 3D imaging by surgeons preoperatively

**Measure:** Anatomical structure recognition comparison

**Time Frame:** Day 0

**Description:** Contribution of 3D modeling comparison to 2D imaging in pre-operative planning

**Measure:** Pre-operative planning contribution

**Time Frame:** Day 0

**Description:** Added value evaluation of 3D modelling compared to 2D imaging for surgeons pre-operatively

**Measure:** Added value evaluation

**Time Frame:** Day 0

**Description:** Surgeons' support evaluation for integrating 3D modelling into routine pre-operative planning

**Measure:** Surgeons' support evaluation in pre-operative routine

**Time Frame:** Day 0

**Description:** Evaluation of the contribution of 2D imaging for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively

**Measure:** 2D imaging evaluation contribution for families' understanding

**Time Frame:** Day 0

**Description:** Evaluation of the contribution of 3D modelling for families in understanding the information (pathology and surgery) delivered by the surgeon to parents pre-operatively

**Measure:** 3D modelling evaluation contribution for families' understanding

**Time Frame:** Day 0

**Description:** Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively

**Measure:** 3D modelling added value evaluation pre-operatively

**Time Frame:** Day 0

**Description:** Contribution of 3D modelling evaluation compared to 2D imaging for surgeons during surgery

**Measure:** 3D modelling added value evaluation during surgery

**Time Frame:** 1 month

**Description:** Consistency evaluation of the 3D imaging with anatomy observed intraoperatively

**Measure:** Consistency evaluation between 3D modelling and anatomy

**Time Frame:** 1 month

**Description:** Surgeons' support evaluation for integrating 3D modeling into their current practice

**Measure:** Surgeons' support evaluation in current practice

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 17 Years

**Minimum Age:** 3 Months

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** thomas.blanc@aphp.fr

**Name:** Thomas BLANC, MD

**Phone:** +33 1 44 49 41 53

**Role:** CONTACT

**Contact 2:**

**Email:** gael.plastow@aphp.fr

**Name:** Gael PLASTOW

**Phone:** +33 1 44 38 18 57

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Paris

**Contacts:**

***Contact 1:***

- **Email:** thomas.blanc@aphp.fr

- **Name:** Thomas BLANC, MD

- **Phone:** +33 1 44 49 41 53

- **Role:** CONTACT

***Contact 2:***

- **Email:** gael.plastow@aphp.fr

- **Name:** Gael PLASTOW

- **Phone:** +33 1 44 38 18 57

- **Role:** CONTACT

**Country:** France

**Facility:** Hôpital Necker Enfants Malades

**Zip:** 75015

#### Overall Officials

**Official 1:**

**Affiliation:** Assistance Publique - Hôpitaux de Paris

**Name:** Sabine SARNACKI, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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 Feb 24:S0022-3468(24)00107-6. doi: 10.1016/j.jpedsurg.2024.02.025. Online ahead of print.

**PMID:** 38461108

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13297

- Name: Pelvic Neoplasms

- Relevance: HIGH

- As Found: Pelvic Tumors

### Condition Browse Module - Meshes

- ID: D000009369

- Term: Neoplasms

- ID: D000010386

- Term: Pelvic Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
