Virtual Reality Technology for Head and Neck Cancer

Overseen By Joseph Curry, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Nasopharyngeal carcinoma, impaired judgement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

160 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies the use of virtual reality technology and three dimensional surgery (3D-surgery) modeling to enhance current treatments in head and neck cancer surgery. Virtual reality 3D-surgery modeling may improve quality of surgical planning and interdisciplinary communication between surgeons and pathologists during the treatment of head and neck squamous cell cancer and ultimately increase the accuracy of planning, the quality of communication, and maximize the outcome patients with head and neck cancer experience throughout treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual Reality Technology for Head and Neck Cancer?

The use of new technologies like surgical simulation and planning, as mentioned in the review, has shown improvements in surgical outcomes, including functional and aesthetic results for head and neck cancer patients. Additionally, augmented reality surgery has been found feasible and accurate in guiding re-resections, which suggests that similar virtual reality technologies could enhance surgical precision and outcomes. ^{1 2 3 4 5}

Is virtual reality technology for head and neck cancer surgery safe for humans?

The first human trial of transoral robotic surgery using a single-port robotic system showed that it is feasible and safe for patients with head and neck cancer. ^{4 5 6 7 8}

How is the treatment of surgical resection for head and neck cancer using virtual reality different from other treatments?

This treatment is unique because it uses virtual reality to create a 3D model of the tumor and surrounding structures, allowing surgeons to plan and practice the surgery in a simulated environment. This helps ensure the safety and accuracy of the operation, which is particularly important given the complex anatomy of the head and neck area. ^{4 9 10 11 12}

Eligibility Criteria

This trial is for adults over 18 with head and neck squamous cell carcinoma, treated at Thomas Jefferson University by a specialized surgeon. Participants must be able to consent. Those with impaired judgment or other risks that affect study compliance or those in another clinical trial can't join.

Inclusion Criteria

Provide signed written informed consent document

I have been diagnosed with a type of throat cancer.

I am older than 18 years.

Exclusion Criteria

Anything that could increase your risk or prevent you from fully participating in the study.

I am able to understand and make decisions about my health care.

You cannot participate if you are already enrolled in another clinical trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Planning

Patients undergo virtual reality 3D tumor resection planning and pre-surgical CT scans are reviewed

2 weeks

1 visit (in-person)

Surgical Resection

Patients undergo surgical resection and a 3D model of the tumor is created and imported into the virtual reality environment

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Treatment Details

Interventions

• Resection
• Virtual Reality 3D-Surgery Modeling

Trial Overview The study tests virtual reality technology and 3D-surgery modeling as tools to improve surgical planning and team communication in treating head and neck cancer, aiming to enhance the precision of surgery plans and patient outcomes.

Participant Groups

Group I: Arm I (VR/3D-CEPs, standard treatment) Experimental Treatment 3 Interventions

Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29 and a 3D model of true tumor is created and imported into the virtual reality environment.

Group II: Arm II (standard treatment) Active Control 2 Interventions

Prior to surgery (day 0-13), patients' pre-surgical CT scans are reviewed per standard of care. Patients then undergo surgical resection on day 14-29.

Resection is already approved in United States, European Union for the following indications:

Approved in United States as Surgical Resection for:

• Colorectal Cancer
• Liver Metastases
• Lung Metastases

Approved in European Union as Surgical Excision for:

• Colorectal Cancer
• Liver Metastases
• Lung Metastases

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Findings from Research

Recent advancements in surgical techniques, including surgical simulation, minimally invasive surgery, and microsurgery, have significantly improved the outcomes of head and neck cancer resection and reconstruction.

These innovations not only enhance the surgical removal of tumors but also lead to better functional and aesthetic results for patients, indicating ongoing progress in the management of head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of surgical resection and reconstruction in head and neck cancer. Traditional versus current concepts. Alfouzan, AF.[2022]

In a study of 51 patients with head and neck squamous cell carcinoma treated with transoral robotic surgery (TORS) and neck dissection (ND), the 3-year local control rate was 92%, indicating high efficacy of this surgical approach.

The presence of positive margins on the resected specimen was identified as the strongest predictor of local recurrence, with a critical threshold of 1.1 mm for margins, suggesting that achieving clear margins is essential for improving local control outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. Warner, L., O'Hara, JT., Lin, DJ., et al.[2022]

Surgery is a primary treatment for head and neck cancer (HNC), but it can lead to various postoperative complications that negatively affect patient outcomes.

Comprehensive pre- and postoperative care, along with vigilant nursing practices, are essential in reducing the incidence of complications, improving quality of life, and potentially extending survival for HNC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative complications in head and neck cancer. Baehring, E., McCorkle, R.[2012]

The study demonstrated that augmented reality can accurately guide surgeons in re-resecting head and neck cancer specimens, achieving a mean relocation error of only 4 mm, which is promising for improving surgical precision.

The overall time taken for the augmented reality protocol, from 3D scanning to alignment, averaged 25.3 minutes, indicating that this technology can be integrated into surgical workflows effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented-Reality Surgery to Guide Head and Neck Cancer Re-resection: A Feasibility and Accuracy Study. Prasad, K., Miller, A., Sharif, K., et al.[2023]

Surgery plays a crucial role in managing head and neck cancers, alongside radiotherapy and chemotherapy, highlighting the importance of surgical techniques in treatment.

Updating and standardizing surgical practices in head and neck oncology can enhance safety and improve patient outcomes, emphasizing the need for quality assurance in these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality assurance in head and neck surgical oncology]. Vergez, S., Jegoux, F., Dolivet, G., et al.[2014]

The article outlines a quality assurance (QA) program developed for the EORTC 1420 phase III trial, which focuses on assessing swallowing function after transoral surgery versus radiation therapy in head and neck cancer patients.

The proposed QA program includes adaptable components tailored to specific surgical procedures and non-adaptable components that set minimal structural requirements for clinical units, aiming to enhance the reliability of surgical trials and potentially inform broader clinical practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 'Best of' and 24954 'larynx preservation' study. Simon, C., Caballero, C., Gregoire, V., et al.[2019]

A study involving 410 patients treated with transoral robotic surgery (TORS) for head and neck cancer showed a high 2-year locoregional control rate of 91.8% and disease-specific survival rate of 94.5%, indicating TORS is an effective treatment option.

Factors such as being female and having tumors in the tonsil were associated with improved survival, while smoking was linked to worse overall mortality, highlighting the importance of patient characteristics in treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncologic Outcomes After Transoral Robotic Surgery: A Multi-institutional Study. de Almeida, JR., Li, R., Magnuson, JS., et al.[2023]

The DaVinci SP system was successfully used for transoral robotic surgery (TORS) in 41 patients with head and neck cancer, demonstrating feasibility and safety with an average operation time of 60 minutes.

This system provided significant technical advantages over previous models, particularly in enhancing visualization and precision during surgery in confined spaces, such as the larynx and hypopharynx.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The First Human Trial of Transoral Robotic Surgery Using a Single-Port Robotic System in the Treatment of Laryngo-Pharyngeal Cancer. Park, YM., Kim, DH., Kang, MS., et al.[2020]

Virtual reality technology was used to create three-dimensional models of complex head and neck carcinomas for eight patients, allowing surgeons to better assess the tumors and their relationship to surrounding structures before surgery.

The use of virtual reality in preoperative evaluations enhanced the safety of surgical procedures by providing a realistic simulation of the surgery, leading to improved planning and execution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of virtual reality in surgical treatment of complex head and neck carcinoma]. Zhou, YQ., Li, C., Shui, CY., et al.[2018]

A pilot study involving 13 reconstructive surgeons showed that a new virtual reality-digital surgical planning (VR-DSP) platform is user-friendly and well-accepted, even by those with little prior VR experience.

Surgeons reported a positive experience with the VR-DSP platform, indicating it could enhance the planning and execution of complex head and neck surgeries, despite some perceived barriers to its implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality digital surgical planning for jaw reconstruction: a usability study. Manzie, T., MacDougall, H., Cheng, K., et al.[2023]

Virtual reality (VR) technology provides a valuable simulated environment for surgeons to practice and plan complex head and neck surgeries, enhancing their skills in dealing with intricate anatomical challenges.

The use of VR in surgical training addresses past limitations of human body models, allowing for more effective preparation in procedures such as congenital craniofacial surgery and tumor resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced surgical technologies for plastic and reconstructive surgery. Rosen, JM.[2022]

The use of a Virtual Reality (VR) simulation model for sentinel lymph node biopsy (SLNB) in head and neck skin cancer patients was rated highly by surgeons for its accuracy (8.3 out of 10), indicating it can effectively aid in pre-operative planning.

Seventy-six percent of surgical residents reported increased confidence after using the VR platform, which was also rated positively as a training tool, suggesting that VR can enhance both surgical preparation and education for residents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality-based training and pre-operative planning for head and neck sentinel lymph node biopsy. Feinmesser, G., Yogev, D., Goldberg, T., et al.[2023]

References

1. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Review of surgical resection and reconstruction in head and neck cancer. Traditional versus current concepts. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Transoral robotic surgery and neck dissection alone for head and neck squamous cell carcinoma: Influence of resection margins on oncological outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Postoperative complications in head and neck cancer. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Augmented-Reality Surgery to Guide Head and Neck Cancer Re-resection: A Feasibility and Accuracy Study. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[Quality assurance in head and neck surgical oncology]. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 'Best of' and 24954 'larynx preservation' study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Oncologic Outcomes After Transoral Robotic Surgery: A Multi-institutional Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The First Human Trial of Transoral Robotic Surgery Using a Single-Port Robotic System in the Treatment of Laryngo-Pharyngeal Cancer. [2020]

9. China pubmed.ncbi.nlm.nih.gov

[Application of virtual reality in surgical treatment of complex head and neck carcinoma]. [2018]

10. Australia pubmed.ncbi.nlm.nih.gov

Virtual reality digital surgical planning for jaw reconstruction: a usability study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Advanced surgical technologies for plastic and reconstructive surgery. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Virtual reality-based training and pre-operative planning for head and neck sentinel lymph node biopsy. [2023]