Pelvic Tumor3D-PEDSURGNCT06418243
Contribution of 3D Modeling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors
An observational study of Pelvic Tumor and Retroperitoneal Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Pelvic Tumor, Retroperitoneal Tumor
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 17 years
- All sexes
- 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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Necker Enfants Malades. Service de Chirurgie Viscérale et Urologie pédiatrique
Paris, Île-de-France Region, 75015
About this study
Official title: Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
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.
Read the 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
- Pelvic Tumor, Retroperitoneal Tumor
- Keywords
- Surgery, 3D-Imaging, MRI, CT Scan, Paediatric surgery, Tumor
- Medical subject headings
- Pelvic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmentation comparison
Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index
Measured: 1 month
Secondary outcomes (11)
Distance comparison
Distance comparison between the reference segmentation and the one obtained by the algorithm using the Hausdorff spacing.
Measured: 1 month
Anatomical structure recognition comparison
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
Measured: Day 0
Pre-operative planning contribution
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
Measured: Day 0
Added value evaluation
Added value evaluation of 3D modelling compared to 2D imaging by using score 5 of the pre-operative questionnaire for operating or external surgeons
Measured: Day 0
Surgeons' support evaluation in pre-operative routine
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
Measured: Day 0
2D imaging evaluation contribution for families' understanding
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
Measured: Day 0
3D modelling evaluation contribution for families' understanding
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
Measured: Day 0
3D modelling added value evaluation pre-operatively
Added value evaluation of 3D modelling compared to 2D imaging for families pre-operatively from score 3 of the family questionnaire
Measured: Day 0
3D modelling added value evaluation during surgery
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
Measured: 1 month
Consistency evaluation between 3D modelling and anatomy
Consistency evaluation of the 3D imaging with anatomy observed intraoperatively from score 2 of the post-operative questionnaire for operating surgeons and their helpers
Measured: 1 month
Surgeons' support evaluation in current practice
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start16 Sep 2024
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pelvic TumorStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Imagine Institute, Ligue contre le cancer, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabine SARNACKI, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418243
- Sponsor's protocol ID
- APHP230680
- Other IDs
- 2023-A02070-45
- Acronym
- 3D-PEDSURG
- Status last verified
- Aug 2026
- First submitted
- 13 May 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31233814Talanki 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.
PubMed 34046959Ibrahim 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.
PubMed 33578590van 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.
PubMed 35200565Bertrand 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.
PubMed 24838739Simons 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.
PubMed 38461108Valls-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.
PubMed 37238380Hampshire 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.
PubMed 36905500Bernhard 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.
PubMed 26162845Youn 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.
PubMed 36717595
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
- ClinicalTrials.gov ID
- NCT06418243
- Acronym / sponsor ID
- 3D-PEDSURG / APHP230680
- Conditions
- Pelvic Tumor, Retroperitoneal Tumor
- Keywords
- Surgery, 3D-Imaging, MRI, CT Scan, Paediatric surgery, Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Imagine Institute, Ligue contre le cancer, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Segmentation comparison
Time frame: 1 month
Comparison of the automatically segmented 3D model to the reference manual segmentation, based on the Dice precision index
11 secondary outcomes
Distance comparison
Time frame: 1 month
Anatomical structure recognition comparison
Time frame: Day 0
Pre-operative planning contribution
Time frame: Day 0
Added value evaluation
Time frame: Day 0
Surgeons' support evaluation in pre-operative routine
Time frame: Day 0
2D imaging evaluation contribution for families' understanding
Time frame: Day 0
3D modelling evaluation contribution for families' understanding
Time frame: Day 0
3D modelling added value evaluation pre-operatively
Time frame: Day 0
3D modelling added value evaluation during surgery
Time frame: 1 month
Consistency evaluation between 3D modelling and anatomy
Time frame: 1 month
Surgeons' support evaluation in current practice
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 31233814Wake 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.
- Background: PubMed 34046959Talanki 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.
- Background: PubMed 33578590Ibrahim 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.
- Background: PubMed 35200565van 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.
- Background: PubMed 24838739Bertrand 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.
- Background: PubMed 38461108Simons 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.
- Background: PubMed 37238380Valls-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.
- Background: PubMed 36905500Hampshire 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.
- Background: PubMed 26162845Bernhard 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.
- Background: PubMed 36717595Youn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabine SARNACKI, MD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Tumor and Retroperitoneal Tumor, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas BLANC, MD (+33 1 44 49 41 53, thomas.blanc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmentation comparison (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06418243, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.