Trials
Search / Trial NCT06418243

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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 13, 2024

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Trial Information

Current as of March 13, 2025

Recruiting

Keywords

Surgery 3 D Imaging Mri Ct Scan Paediatric Surgery Tumor

ClinConnect Summary

This clinical trial is looking at how 3D models of tumors in children can help surgeons plan for surgery more effectively than traditional 2D images. The study will compare the accuracy of these 3D models, created automatically, to images segmented by hand. To gather information, parents, surgeons, and caregivers will answer questions about their experiences with both types of images.

Children between 3 months and under 18 years old who have a pelvic or retroperitoneal tumor that requires imaging tests like MRI or CT scans may be eligible to participate. It's important that these children do not have any conditions that would prevent them from safely undergoing these imaging tests. Participants can expect to share their opinions about the 3D models and help improve surgical planning for future patients. The trial is currently recruiting, and everyone involved, including parents and medical staff, must agree to take part.

Gender

ALL

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

Trial Officials

Sabine SARNACKI, MD

Study Chair

Assistance Publique - Hôpitaux de Paris

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0