Using 3D models to improve surgery for children's pelvic and retroperitoneal tumors
Non-interventional Study on the Contribution of 3D Modelling in Surgical Management of Pediatric Retroperitoneal and Pelvic Tumors Compared to 2D Imaging
This study is testing if using 3D models of tumors can help doctors plan surgeries better for children with pelvic and retroperitoneal tumors compared to regular 2D images.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 3 Months to 17 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06418243 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of automatically generated 3D models of tumors to traditional 2D images in aiding surgical planning for pediatric patients. Parents, patients, and surgical teams will evaluate the 3D models against standard 2D images through questionnaires. The study aims to enhance understanding and communication regarding tumor characteristics before surgery, utilizing MRI and CT scans as part of routine care. The focus is on children with pelvic or retroperitoneal tumors who require imaging prior to surgical intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to less than 18 years with pelvic or retroperitoneal tumors requiring imaging for surgery.
Not a fit: Patients with contraindications for MRI or CT scans, or those needing imaging under general anesthesia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better pre-operative understanding for families.
How similar studies have performed: While the use of 3D imaging in surgery is gaining traction, this specific approach in pediatric tumors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital Necker Enfants Malades — Paris, France (Recruiting)
Study contacts
- Study coordinator: Thomas BLANC, MD
- Email: thomas.blanc@aphp.fr
- Phone: +33 1 44 49 41 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.