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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date February 2024
Source Thomas Jefferson University
Contact Joseph Curry, MD
Phone 215-955-6784
Email joseph.curry@jefferson.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

PRIMARY OBJECTIVES: To assess the potential for preoperative virtual reality and 3D pathological modeling to reduce total number of margin events as defined in the study as the number of positive frozen margins, number of positive final margins and the number of unexpected defect driven margins. SECONDARY OBJECTIVES: To assess the impact of preoperative virtual reality and 3D pathologic modeling as treatment for head and neck squamous cell carcinoma on event free survival (EFS) at 18-36 months after resection as defined by recurrence at the primary site. TERTIARY OBJECTIVE: I. To evaluate the quality of existing interdisciplinary intraoperative communication using the proposed VR/3D-case enhancement protocols (CEPs) as an evaluating medium. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (VR/3D-CEPs + STANDARD TREATMENT): Prior to surgery (day 0-13), patients undergo virtual reality 3D tumor resection via VR/3D-CEPs. Patients' pre-surgical computed tomography (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. ARM II (STANDARD TREATMENT): 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. After completion of study intervention, patients are followed for up to 36 months.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Medical Device Usage and Evaluation
Undergo virtual reality imaging via VR/3D-CEPs
Best Practice
Receive standard of care
Procedure:
Resection
Undergo surgical resection

Locations

Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

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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