Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Preoperative Virtual Reality and 3D Pathologic Modeling as Treatment for Head and Neck Squamous Cell Carcinoma
NCT number | NCT05031910 |
Other study ID # | 21D.079 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 4, 2022 |
Est. completion date | June 2027 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | June 2027 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosed with cancer of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, T1-T4) - Receiving treatment at Thomas Jefferson University - Center City by a fellowship-trained HNC surgeon - Eligible for definitive resection - Age > 18 - Provide signed written informed consent document Exclusion Criteria: - Impaired judgement or those unable to provide informed consent - Any factor that would place the patient at increased risk or preclude the individual's full compliance with or completion of the study - Nasopharyngeal carcinoma - Contraindications for surgery - Enrollment in other clinical trial |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Margin events | Will be defined as the number of positive margins along with the number of unexpected defect driven margins. Will be collected for patients in the control group and patients treated with the use of preoperative planning with virtual reality (VR). Margin events will be defined as binary (yes/no) on post-operative survey to be completed by surgeons. Logistic regression will be used to evaluate of a difference in any margin event between study groups (3 dimensional [3D] VR vs. control) adjusted for surgeon. | Up to Completion of surgical resection | |
Secondary | Event free survival | Logistic regression will be used to estimate an odds ratio and 95% confidence interval (CI). | The time from completion of treatment to marginal recurrence of tumor at the primary site, assessed up to 3 years |
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