Neuroblastoma is one of the most common extracranial solid tumors in children. It
originates from cells of the neural crest, and can be located at the adrenal level, or in
the sympathetic chains from the neck to the pelvis. Surgery still remains a mainstay part
of the treatment and this is particularly challenging when IDRF are present. Adequate
surgical planning, based on images such as CT Scans, MRI and/or nuclear medicine is
crucial. This project seeks to compare; surgical time, GTR percentage and complications
between standard surgical planning with biplanar 2D images vs the use of virtual reality
as a planning tool, through the segmentation and post-processing of medical images and
the visualization of 3D models with immersive virtual reality glasses (VR). The software
that will be used for the segmentation and generation of 3D images will be Materialise
Mimics® Innovation Suite and the images can be viewed using the Meta Quest 2® virtual
reality glasses and the Materialise Mimics Viewer® software, which sends the processed
images to be seen only by the treating surgeon, without patient data.
The study design will be of the type of multicenter clinical trial, controlled and with
simple randomization. All patients with a debut diagnosis of neuroblastoma in stage L1,
L2 or M who have a surgical indication will be recruited. Surgical time, complications,
amount of resection (GTR), surgeon's satisfaction as well as surgical anatomy
comprehension will be compared. An invitation to participate will be sent to hospitals
around the world.
Additional locations may be listed on ClinicalTrials.gov for NCT05781919.
Locations matching your search criteria
United States
Tennessee
Memphis
Saint Jude Children's Research HospitalStatus: Active
Name Not Available
The study design will be a prospective, controlled, multicenter clinical trial with
simple randomization, in patients with neuroblastoma in stages L1, L2 and M who require
resective surgery. It will be a single-blind study (the patient will not know to which
group he/she will be assigned)
There will be two groups, which will be studied in parallel.
- Group A: Surgical planning with iRV.
- Group B: Surgical planning without iRV.
The study group will be A, where the treating surgeon will use iVR, through the use of
MetaQuest 2 ® glasses, as part of the surgical planning based on the 2D images of each
patient (CT or MRI), and the control group will be B, where only the 2D images will be
used for surgical planning.
Randomization will be done through the database software REDCap®, which will assign each
patient entering the study to one or another group, when the surgery is indicated.
If the randomization corresponds to group A, the participating centers must send the 2D
DICOM images to the research team of the coordinating center for segmentation and
post-production into 3D images ready for viewing. This process will be carried out at the
3D4H Unit of the Hospital Sant Joan de Déu, with Materialise MIMICS® software, which
generates a VR image file for viewing and control with the Meta Quest2® glasses. This
file, encrypted and anonymized, will be sent to the corresponding participating center by
e-mail, which can be opened only by the treating surgeon (who will have to create a
username and password to access) and will not include the patient's identification data,
only a unique code. The surgeon will use the aforementioned glasses to visualize and
control the images. Once the VR images have been studied, the team will perform the
surgery and record the intraoperative information on the data collection form.
Each center has to obtain its own Meta Quest 2 or compatible goggles.
In the event that the patient is randomized to Group B, the surgical team will do the
surgical planning with 2D imaging, perform the surgery, and record the intraoperative
information on the data collection form.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationHospital Sant Joan de Deu
Principal InvestigatorLucas Krauel
