Use of Virtual Reality for Surgical Planning in Neuroblastoma

Study Purpose

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.#46;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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 18 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05781919
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hospital Sant Joan de Deu
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lucas Krauel, PhD
Principal Investigator Affiliation	Hospital Sant Joan de Deu
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Spain
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Group A

Patients with L1, L2 or M INRGSS neuroblastoma in which their surgical planning will be performed using gold standard imaging (TC and/or MRI) and immersive virtual reality HMD device.

Active Comparator: Group B

Patients with L1, L2 or M INRGSS neuroblastoma in which their surgical planning will be performed using only gold standard imaging (TC and/or MRI)

Interventions

Other: - Immersive virtual reality imaging

Segmentation and post-processing of DICOM 2D imaging will generate a 3D file able to be used in immersive virtual reality googles, for further analysis of the tumor and anatomic structures that could facilitate surgical planning.

Other: - Gold standard imaging

Use of traditional gold standard 2D imaging (TC and/or MRI) for surgical planning

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Sant Joan de Déu, Esplugues De Llobregat, Barcelona, Spain

Status

Recruiting

Address

Hospital Sant Joan de Déu

Esplugues De Llobregat, Barcelona, 08095

Site Contact

Rosa Balastegui

rosamaria.balastegui@sjd.es

34932804000 #71704

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