VRNB: Use of Virtual Reality for Surgical Planning in Neuroblastoma

Sponsor

Hospital Sant Joan de Deu (Other)

Overall Status

Recruiting

CT.gov ID

NCT05781919

Collaborator

(none)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 (or compatible set) 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 diagnosis of neuroblastoma in stage L1 and L2 who have a surgical indication will be recruited, from April1, 2023 to October 31, 2024 (18 months). 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.

Condition or Disease	Intervention/Treatment	Phase
Neuroblastoma	Other: Immersive virtual reality imaging Other: Gold standard imaging	N/A

Detailed Description

The study design will be a prospective, controlled, multicenter clinical trial with simple randomization, in patients with neuroblastoma in stages L1 and L2 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, with two branches each, which will be studied in parallel.

Group 1:
Branch A: L1 2D + VR
Branch B: L1 2D

Group 2:

Branch C: L2 2D + VR
Branch D: L2 2D

The study branches will be A and C, where the treating surgeon will use VR, through the use of MetaQuest 2 ® glasses (or compatible VR set), as part of the surgical planning based on the 2D images of each patient (CT or MRI), and the control branches will be B and D, where only the 2D images will be used for surgical planning.

Randomization will be done by means of a computer program, which will assign each patient entering the study to one or another branch of the group, when the surgery is indicated.

Once each patient has been randomized, the different participating centers will be informed to which branch they should be assigned. When corresponding to branches A or C, 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 the B or D branches, the surgical team will do the planning with the 2D (standard of care) images obtained, perform the surgery, and record the intraoperative information on the data collection form.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Use of Immersive Virtual Reality (iVR) for Surgical Planning in Neuroblastoma: A Randomized and Controlled Multicentric Clinical Trial

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Branch A: L1 2D + iRV Patients with L1 neuroblastoma that will be planned using gold standard imaging (TC and/or MRI) and immersive virtual reality	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.
Active Comparator: Branch B: L1 2D Patients with L1 neuroblastoma that will be planned using only gold standard imaging (TC and/or MRI)	Other: Gold standard imaging Use of traditional gold standard 2D imaging (TC and/or MRI) for surgical planning
Experimental: Branch C: L2 2D + iVR Patients with L2 neuroblastoma that will be planned using gold standard imaging (TC and/or MRI) and immersive virtual reality	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.
Active Comparator: Branch D: L2 2D Patients with L2 neuroblastoma that will be planned using only gold standard imaging (TC and/or MRI)	Other: Gold standard imaging Use of traditional gold standard 2D imaging (TC and/or MRI) for surgical planning

Outcome Measures

Primary Outcome Measures

Surgical time [From date of randomization until three months after surgery]
Reduction in surgical time when iVR is used
Percentage of tumor resection [From date of randomization until three months after surgery]
Improvement in percentage of resection when iVR is used

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pediatric patients (0-18 years) with neuroblastoma in L1 or L2 stages (INGRSS) who have surgical indication for resection.

Exclusion Criteria:

Patients with relapsed neuroblastoma.
Patients with M or MS stage neuroblastoma.
Patients with other than abdominal or pelvic location of neuroblastoma.
Patients with previous surgeries for the current diagnosis of neuroblastoma (except the biopsy that made the diagnosis).
Non-acceptance of informed consent.