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

Trial Summary

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 data supports the idea that 3D Technology for Head and Neck Surgery is an effective treatment?

The available research shows that 3D Technology for Head and Neck Surgery is effective because it improves surgical planning and outcomes. For example, it helps surgeons better understand the location and size of problems, leading to more precise surgeries and better results. In cranial-facial and laryngeal surgeries, it saves time and improves recovery. Compared to traditional methods, 3D planning increases efficiency and accuracy, especially in complex surgeries like head and neck reconstruction. It also helps in planning dental implants and reconstructive surgeries, making the process more efficient and improving patient outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment 3D Technology for Head and Neck Surgery?

Research shows that using 3D imaging and virtual surgical planning in head and neck surgeries improves the accuracy of surgical planning, reduces operative time, and enhances patient outcomes. These technologies help surgeons visualize complex structures better and plan surgeries more precisely, leading to more efficient and effective treatments. ^{1 2 3 4 5}

What safety data exists for 3D technology in head and neck surgery?

The research indicates that 3D technology, including 3D CT and virtual surgical planning, has been used safely in head and neck surgeries, such as cranial-facial and laryngeal procedures, and in reconstructive surgeries. Studies show improvements in preoperative planning, operative efficiency, accuracy, and postoperative outcomes. The technology allows for precise surgical planning and execution, which can save operative time and improve results. It has been applied safely in both primary and secondary reconstructive cases, particularly in oncologic mandibular and maxillary reconstructions. ^{1 5 6 7 8}

Is 3D technology for head and neck surgery safe for humans?

Research indicates that 3D technology, including virtual surgical planning, is used safely in head and neck surgeries, improving planning and outcomes without noted safety concerns. ^{1 5 6 7 8}

Is 3D technology a promising treatment for head and neck surgery?

Yes, 3D technology is a promising treatment for head and neck surgery. It helps doctors plan surgeries better by creating detailed 3D images of the area they will operate on. This makes surgeries more accurate, saves time, and can lead to better recovery for patients. ^{1 5 6 9 10}

How does 3D technology for head and neck surgery differ from other treatments?

3D technology for head and neck surgery is unique because it uses three-dimensional imaging to create detailed, life-like models of the patient's anatomy, which helps surgeons plan and execute surgeries with greater precision. This approach improves the accuracy of surgical planning, allows for precise bone removal, and can lead to better postoperative outcomes compared to traditional methods. ^{1 5 6 9 10}

What is the purpose of this trial?

The purpose of this study is to test how the new 3D technology can be used to help improve the surgeon's ability to use information from standard imaging scans to guide head and neck surgery. Researchers will use the Scaniverse app during a standard ultrasound to create 3D images of participants' head and neck before their standard surgery. Researchers will see if the creation of a 3D framework profile with superimposed standard imaging scan information can be useful to the surgeon for guiding head and neck surgery

Research Team

Snehal Patel, MD, FRCS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

3-D CT for cranial facial and laryngeal surgery. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Innovative methods and developments in oral care. 3D planning in oral and maxillofacial surgery]. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Virtual surgical planning in fibula free flap head and neck reconstruction: A systematic review and meta-analysis. [2022]

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

Evaluation of the Accuracy of Virtual Planning in Orthognathic Surgery: A Morphometric Study. [2019]

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

Virtual Surgical Planning for Oncologic Mandibular and Maxillary Reconstruction. [2022]

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

Adjunctive use of medical modeling for head and neck reconstruction. [2022]

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

Impact of 3D virtual planning on reconstruction of mandibular and maxillary surgical defects in head and neck oncology. [2022]

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

Clinical evaluation of an automated virtual surgical planning platform for mandibular reconstruction. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Three-dimensional visualization for preoperative planning and evaluation in head and neck surgery]. [2009]

10. India pubmed.ncbi.nlm.nih.gov

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