Using virtual reality to plan surgeries for children with neuroblastoma
Use of Immersive Virtual Reality (iVR) for Surgical Planning in Neuroblastoma: A Randomized and Controlled Multicentric Clinical Trial
This study is testing if using virtual reality for surgery planning can help doctors operate more effectively on children with neuroblastoma compared to traditional 2D imaging.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Hospital Sant Joan de Deu Academic / other |
| Locations | 1 site (Esplugues De Llobregat, Barcelona) |
| Trial ID | NCT05781919 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of using immersive virtual reality (VR) technology for surgical planning in pediatric patients with neuroblastoma. It will compare two groups: one using standard 2D imaging for surgical planning and another utilizing VR to visualize 3D models generated from medical images. The study will be conducted in a multicenter setting, with randomization to ensure unbiased assignment to either the VR or standard planning group. The primary outcomes will include surgical time, percentage of gross total resection (GTR), and complications associated with the surgeries.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 0-18 years diagnosed with neuroblastoma in stages L1, L2, or M who require surgical resection.
Not a fit: Patients with relapsed neuroblastoma or those who have had previous surgeries for their current diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance surgical precision and outcomes for children undergoing surgery for neuroblastoma.
How similar studies have performed: While the use of VR in surgical planning is an emerging field, similar studies have shown promising results in other surgical specialties, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients (0-18 years) with neuroblastoma in L1, L2 or M stages (INGRSS) who have surgical indication for resection. Exclusion Criteria: * Patients with relapsed neuroblastoma. * Patients with neuroblastoma other than abdominal or pelvic location. * Patients with previous surgery for the current diagnosis of neuroblastoma (excluding the biopsy that made the diagnosis). * Patients who have undergone laparoscopic surgery. * Patients operated on by a surgical team other than the one that usually treats oncology children at your center. * Failure to obtain informed consent. * Lack of complete medical records.
Where this trial is running
Esplugues De Llobregat, Barcelona
- Hospital Sant Joan de Déu — Esplugues De Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Lucas Krauel, PhD — Hospital Sant Joan de Deu
- Study coordinator: Albert Pasten, MD
- Email: apastego44@alumnes.ub.edu
- Phone: 671589972
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.