Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task (SPeAR)

Head and neck cancers have one of the highest recurrence rates among solid malignancies, and recurrence is strongly correlated with overall survival. Reducing recurrence rates depends, in part, on the surgeon's ability to accurately re-resect areas of positive or close margins during surgery. Currently, margin status is communicated primarily through verbal descriptions between the surgeon and pathologist, which can be imprecise. This challenge is further compounded by the deformable nature of soft tissues, as once the specimen is resected, the shape and size of the specimen change, making it difficult to accurately map the specimen's margins back onto the surgical site.

Emerging technologies -such as augmented reality (AR), 3D scanning, and advanced soft tissue modeling- offer promising solutions for improving surgical navigation and precision. Building on these advances, an AR-based surgical navigation system was developed specifically for head and neck tumor resections. The system uses a 3D scanner to generate virtual models of both the resected specimen and the patient's surgical site, as demonstrated in prior work. A soft tissue modeling algorithm is then applied to account for specimen shrinkage and deformation, enabling accurate tracking of positive tumor margins. This guidance information is visualized through an AR headset, which overlays the margin data directly onto the patient's surgical site, providing surgeons with real-time visual guidance during re-resection.

In this study, the goal is to evaluate the benefits and usability of this novel navigation software, compared to the standard of care. By assessing surgeon performance and user experience in cadaveric tasks with and without the AR system to identify strengths, limitations, and opportunities for refinement of the system, ultimately advancing surgical precision and improving patient outcomes by reducing recurrence rates.

Study Overview

• Status: Recruiting
• Conditions: Physician; Surgical; Resident Doctor; Surgeon; Resident Surgeon; Fellow
• Intervention / Treatment: Other: Augmented Reality

Detailed Description

Augmented reality (AR) technology, combined with computer vision algorithms, offers significant potential to enhance surgical visualization by generating GPS-like spatial maps over the patient's anatomy. This study aims to evaluate the usability and impact of our AR surgical guidance system, delivered through Microsoft HoloLens 2 (or equivalent AR/VR goggles such as Magic Leap or Apple Vision Pro), among surgeons while they complete various surgical tasks on cadaveric specimens. Specifically, an assessment of how the AR system influences surgeon performance and user experience during tasks such as suturing and specimen relocation, performed both with and without AR assistance.

Task accuracy (e.g., resection precision) will be measured and survey responses will be collected to assess the system's usability, ease of use, and comfort. Building on prior work where the investigators validated the feasibility and accuracy of AR-guided surgical holograms, this study focuses on advancing the evaluation of the system's usability and impact on performance. The goal is to generate insights into the application of AR guidance in head and neck tumor resection, ultimately contributing to improved intraoperative surgical precision and patient outcomes.

• Study Type: Observational
• Enrollment (Estimated): 51

Contacts and Locations

• Study Contact: Name: Jie Ying Wu Assistant Professor of Computer Science, PhD; Phone Number: 615-343-4996; Email: JieYing.Wu@vanderbilt.edu

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Jie Ying Wu Assistant Professor of Computer Science, PhD; Phone Number: 615-343-4996; Email: JieYing.Wu@vanderbilt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Surgeon-physician, surgical fellow, or post-graduate year 1, 2, 3, 4 and 5 (PGY2-5) resident physicians

Description

Inclusion Criteria:

1. Post-graduate year 1, 2, 3, 4 and 5 (PGY2-5) resident physicians. (no age limit)
2. Surgical fellows.
3. Attending physicians.
4. Prior cadaver lab or surgical experience.
5. Any surgeon, regardless of training and experience, who has been involved in the surgeon-pathologist interaction during surgical resection for frozen section and margin clearance assessment.

Exclusion Criteria:

1. Non-physician surgery providers.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Augmented Reality (AR); Participants will be asked to localize simulated margins on tissue resection beds on a fresh-frozen cadaver head. Specimens of skin, buccal, or tongue tissue will be resected by the research team beforehand. Participants will be asked to place pins or stitches where the indicated targets are located. These positions will be recorded by the research team. Participants will first receive oral guidance only, corresponding to common descriptions between pathologists and surgeons. Participants will then reproduce the same task with AR guidance. In this case, the target will be displayed in the see-through AR headset. The target will be overlaid on the resection bed site and follow your head's movements.

Other: Augmented Reality; Task accuracy will be evaluated by measuring distances between the points identified with and without AR guidance, and the pathologist-intended target locations. Participants will then complete post-tasks surveys and interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Task accuracy (e.g., resection precision)	Surgeon performance of target re-localization compared with and without the AR-headset.	within 90 minutes of AR-guided use
User Experience	Assess AR usability, ease of use, and comfort, through surgeon feedback surveys	immediately after the AR-guided task.
Accuracy of overlay alignment	This will validate the accuracy of overlay alignment through landmark-based (tumor margin relocation) error metrics, which support precision of re-resection tasks.	within 90 minutes of completing the AR-guided task.

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Vanderbilt University
• Investigators: Principal Investigator: Michael Topf, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 30, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: surgical; physician; surgeon; doctor; resident doctor; fellow; resident surgeon
• Other Study ID Numbers: 251090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NIH requires through Data Management and Sharing Plans (DMSP) that all data collected during the research project be archived indefinitely and shared with the community after the project termination. De-identified data will then be transferred to Open Science Framework (OSF).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No