NeuroblastomaVRNBNCT05781919
Use of Virtual Reality for Surgical Planning in Neuroblastoma
A study testing Immersive virtual reality imaging and Gold standard imaging in people with Neuroblastoma, run by Hospital Sant Joan de Deu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Immersive virtual reality imaging and Gold standard imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients (0-18 years) with neuroblastoma in L1, L2 or M stages (INGRSS) who have surgical indication for resection.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08095
Rosa Balastegui, 34932804000 ext. 71704, rosamaria.balastegui@sjd.es
About this study
Official title: Use of Immersive Virtual Reality (iVR) for Surgical Planning in Neuroblastoma: A Randomized and Controlled Multicentric Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Neuroblastoma
- Being tested
- Immersive virtual reality imaging, Gold standard imaging
- Keywords
- virtual reality, neuroblastoma, surgery, planning, cancer, childhood
- Medical subject headings
- Neuroblastoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality imagingOther
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.
Gold standard imagingOther
Use of traditional gold standard 2D imaging (TC and/or MRI) for surgical planning
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Other: Immersive virtual reality imaging |
| Group B | Active comparator | 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) Receives: Other: Gold standard imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
Reduction in surgical time when iVR is used
Measured: From date of randomization until three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sant Joan de Deu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucas Krauel, PhD, Principal investigator, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781919
- Sponsor's protocol ID
- PIC-44-23
- Acronym
- VRNB
- Status last verified
- May 2023
- First submitted
- 10 Mar 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Immersive Virtual Reality (iVR) for Surgical Planning in Neuroblastoma: A Randomized and Controlled Multicentric Clinical Trial
- ClinicalTrials.gov ID
- NCT05781919
- Acronym / sponsor ID
- VRNB / PIC-44-23
- Conditions
- Neuroblastoma
- Keywords
- virtual reality, neuroblastoma, surgery, planning, cancer, childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospital Sant Joan de DeuUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Immersive virtual reality imagingPatients 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. |
| Group B | Active comparator | Other: Gold standard imagingPatients with L1, L2 or M INRGSS neuroblastoma in which their surgical planning will be performed using only gold standard imaging (TC and/or MRI) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients (0-18 years) with neuroblastoma in L1, L2 or M stages (INGRSS) who have surgical indication for resection.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive virtual reality imagingSegmentation 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 | Group A |
| Gold standard imagingUse of traditional gold standard 2D imaging (TC and/or MRI) for surgical planning | Other | Group B |
Primary outcome
Surgical time
Time frame: From date of randomization until three months after surgery
Reduction in surgical time when iVR is used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas Krauel, PhD principal investigator
Hospital Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality imaging and Gold standard imaging in people with Neuroblastoma, run by Hospital Sant Joan de Deu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Pasten, MD (671589972 ext. 82455, apastego44@alumnes.ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical time (time frame: From date of randomization until three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.