3D Technology for Head and Neck Surgery

Recruiting at 6 trial locations

Overseen By Snehal Patel, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Previous head and neck surgery, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D technology (Three-Dimensional Imaging Technology) to assist surgeons during head and neck surgeries. Surgeons will use the Scaniverse app to create 3D images from standard scans to guide them in surgery. The goal is to determine if these 3D images offer better information for the procedure. Individuals scheduled for head and neck surgery with planned standard imaging scans may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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 seems focused on imaging and surgery, so it's best to ask the study team for guidance.

What prior data suggests that this 3D technology is safe for head and neck surgery?

Research has shown that using 3D technology in head and neck surgery is generally safe. Studies have found that virtual surgical planning, which involves creating a detailed 3D model of the surgical area, enhances surgical accuracy. This technology is widely used across various types of surgery, including head and neck procedures, and has become common practice in many locations.

Minor issues, such as exposure of the underlying framework or mild inflammation of the mouth lining, have been observed. However, these problems are typically minor and do not lead to serious complications like surgical repair failure or implant loss.

Overall, 3D technology in surgical planning is well-tolerated. It enhances surgical precision and customization, transforming surgical practices by improving safety and outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of 3D technology in head and neck surgery because it offers a cutting-edge approach that traditional surgical methods can't match. Unlike conventional techniques, which often rely on 2D imaging, 3D technology provides a detailed and accurate visualization of the complex structures in the head and neck. This can potentially lead to more precise surgical planning and execution, reducing the risk of complications and improving patient outcomes. By allowing surgeons to better map out their approach, this technology could transform the way head and neck surgeries are performed, enhancing both safety and effectiveness.

What evidence suggests that this 3D technology is effective for head and neck surgery?

Research has shown that 3D technology in head and neck surgery can enhance surgical planning and outcomes. In this trial, participants scheduled for head and neck surgery will benefit from 3D technology. Studies have found that virtual surgical planning creates precise guides and implants, increasing surgical accuracy. This technology also speeds up surgeries and improves efficiency. It aids in creating custom implants that fit well and remain secure. These advantages suggest that 3D technology could effectively guide head and neck surgeries. ^{1 2 3 4 6}

Who Is on the Research Team?

Snehal Patel, MD, FRCS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who require surgery for a head and neck disorder. Participants must be suitable candidates for standard imaging scans used to guide their upcoming surgeries.

Inclusion Criteria

I can understand and sign the consent form myself, or have someone legally allowed to do it for me.

I am scheduled for head or neck surgery at MSK.

I am scheduled for standard imaging tests like US, CT, MRI, or PET at MSK.

Exclusion Criteria

Any condition which, in the judgement of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study

I have had surgery or radiation therapy on my head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Imaging

Researchers use the Scaniverse app during a standard ultrasound to create 3D images of participants' head and neck before their standard surgery

1-2 weeks

Surgery and Intraoperative Guidance

Participants undergo head and neck surgery with the aid of the 3D framework profile with superimposed standard imaging scan information

1 day

Follow-up

Participants are monitored for the success of the imaging technique and any postoperative outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D Technology

Trial Overview The study is testing the effectiveness of using the Scaniverse app to create 3D images from standard ultrasound scans, which may help surgeons in planning and performing head and neck surgeries.

How Is the Trial Designed?

Group I: Participants scheduled for head and neck surgery Experimental Treatment 2 Interventions

Participants are scheduled to undergo head and neck surgery in the Surgery Head and Neck Service at MSK

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Three-dimensional imaging technology significantly enhances the assessment and surgical planning for patients with head and neck conditions, allowing for more accurate visualization of tumors and anatomical structures.

This technique has been particularly beneficial in preoperative planning for tumor resections, improving surgical precision and potentially reducing operative time and enhancing postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3-D CT for cranial facial and laryngeal surgery. Zinreich, SJ., Mattox, DE., Kennedy, DW., et al.[2016]

Virtual surgical planning (VSP) using computer-aided design and modeling significantly enhances preoperative planning and operative efficiency in complex head and neck reconstruction, leading to better postoperative outcomes.

VSP allows for immediate dental implantation in selected patients, increasing the chances of successful dental restoration after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Surgical Planning for Oncologic Mandibular and Maxillary Reconstruction. Myers, PL., Nelson, JA., Rosen, EB., et al.[2022]

In a study of 17 patients undergoing two-jaw computer-assisted orthognathic surgery, the accuracy of the surgical outcomes was high, with 12 patients showing average linear differences of less than 1 mm between the virtual surgical plan and the actual postoperative results.

The findings suggest that computer-aided planning in orthognathic surgery can lead to precise outcomes, as most patients had discrepancies of less than 2 mm, indicating effective surgical execution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Accuracy of Virtual Planning in Orthognathic Surgery: A Morphometric Study. Zavattero, E., Romano, M., Gerbino, G., et al.[2019]

The use of advanced imaging techniques like cone beam computed tomography and 3D stereophotogrammetry allows for the precise reconstruction of a patient's 3D head model, enabling objective assessment of dental and facial anomalies.

3D treatment planning has become essential in oral and maxillofacial surgery, guiding decisions on jaw repositioning, bone augmentation, and dental implant placement, ultimately improving surgical outcomes and healthcare efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Innovative methods and developments in oral care. 3D planning in oral and maxillofacial surgery]. Xi, T., Baan, F., Verhulst, AC., et al.[2023]

Virtual Surgical Planning (VSP) significantly reduces both intraoperative and ischaemic times in head and neck reconstructions using fibula free flaps, improving surgical efficiency based on a review of 23 studies involving 713 patients.

VSP also enhances the accuracy of orthognathic outcomes compared to traditional methods, with no significant increase in complication rates, indicating it is a safe and effective alternative for these complex surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual surgical planning in fibula free flap head and neck reconstruction: A systematic review and meta-analysis. Tang, NSJ., Ahmadi, I., Ramakrishnan, A.[2022]

Digital technology significantly enhances preoperative planning for head and neck surgeries by allowing surgeons to simulate procedures, which improves surgical accuracy.

These advancements in digital technology have broad applications, including in medical devices, surgical models, and tissue engineering, indicating a transformative impact on surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of simulator and digital technologies in head and neck reconstruction. Alfouzan, AF.[2022]

Three-dimensional medical modeling has proven to be accurate and reproducible in head and neck reconstruction surgery, aiding in diagnostics, surgical preplanning, and reducing operating times.

Recent advancements in rapid prototyping and patient-specific tissue engineering suggest that these models could further enhance patient outcomes and broaden their applications in complex surgical cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive use of medical modeling for head and neck reconstruction. Zenga, J., Nussenbaum, B.[2022]

3D virtual planning significantly enhances the accuracy of surgical procedures for reconstructing mandibular and maxillary defects in head and neck cancer patients, allowing for better control over tumor margins during surgery.

The ability to create patient-specific implants through 3D technology enables tailored solutions for individual cases, but requires careful consideration of biomechanical principles and the effects of prior treatments like radiotherapy on reconstruction outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of 3D virtual planning on reconstruction of mandibular and maxillary surgical defects in head and neck oncology. Witjes, MJH., Schepers, RH., Kraeima, J.[2022]

The study evaluated a custom automated virtual surgical planning (VSP) software in 25 patients undergoing segmental mandibular reconstruction, showing high accuracy with minimal deviations from the surgical plan (average deviations of 2.32 mm in width and 2.39 mm in projection).

The use of this automated VSP significantly reduced operative time and length of hospital stay compared to 25 historical cases, while maintaining a similar complication rate, indicating its efficacy and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of an automated virtual surgical planning platform for mandibular reconstruction. Wang, E., Durham, JS., Anderson, DW., et al.[2021]

This study explores the potential benefits of using three-dimensional visualization techniques for preoperative planning in head and neck surgery, highlighting the need for standardized methods in this area.

The research discusses various segmentation and visualization techniques that could improve tumor volumetry and surgical planning compared to traditional computed tomography, although no direct comparisons of efficacy were made in this study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Three-dimensional visualization for preoperative planning and evaluation in head and neck surgery]. Fischer, M., Straus, G., Gahr, S., et al.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9394458/

Editorial: Virtual surgical planning and 3d printing in head ... The Research Topic of “virtual surgical planning and 3D printing in head and neck tumor resection and reconstruction” aims to collect the most recent evidence.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074879832400060X

Impact of virtual surgical planning and three-dimensional ... This study aims to assess the impact of VSP on time to surgery (TS). Materials and methods. All patients who underwent FFF for oral cavity cancer between 2007 ...

3. journals.lww.com journals.lww.com/prsgo/fulltext/2025/10000/future_applications_for_3_dimensional_printed.77.aspx

Future Applications for 3-dimensional Printed Virtual Surgical Three-dimensional printing (3DP) has been used in many surgical specialties for virtual surgical planning, such as head and neck surgery, ...

4. scholars.houstonmethodist.org scholars.houstonmethodist.org/en/publications/use-of-three-dimensional-technology-for-virtual-surgical-planning

Use of Three-Dimensional Technology for Virtual Surgical ... This plan is used to create surgical guides and implants with high accuracy, which subsequently increase efficiency, reduce costs, and ...

5. frontiersin.org frontiersin.org/research-topics/18308/virtual-surgical-planning-and-3d-printing-in-head-and-neck-tumor-resection-and-reconstruction/magazine

Virtual Surgical Planning and 3D Printing in Head ... Results: All patient-specific implants showed primary stability and were clinically stable throughout the observation period. Definitive prosthodontic ...

6. mdpi.com mdpi.com/2038-9582/14/3/33

3D-Printed Models Are an Innovation Becoming Standard ... Conclusions: 3D printing technology, especially when combined with AI, is reshaping modern surgery by improving both accuracy, safety, and personalized ...