Head and Neck Cancer Patient Symptom and Oncologic Outcomes

Head and Neck Cancer Patient Symptom and Oncologic Outcomes as a Function of Head and Neck Volume Changes

This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.

Study Overview

• Status: Completed
• Conditions: Lymphedema of the Head and Neck
• Intervention / Treatment: Procedure: Imaging Technique

Detailed Description

PRIMARY OBJECTIVES:

I. To develop a specialized and mobile 3D surface scanning application to assess and monitor head and neck lymphedema.

II. To confirm optimal positioning when volumetrically assessing head and neck lymphedema using 3D technologies as consistent with standard plastic surgery departmental protocol.

III. To quantify and serially track changes in head and neck lymphedema in patients with pathologies and correlate these changes with overall patient well-being and disease progression.

OUTLINE:

Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with pathologies leading to head and neck lymphedema
• Individuals with minimal or no facial hair
• Patients of sound mentation, who are able to execute informed decision-making

Exclusion Criteria:

• Any health conditions or history of non-compliance that affect the study will preclude study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening (3D scan); Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.	Procedure: Imaging Technique; Undergo 3D scanning; Other Names: Diagnostic Imaging Technique; Imaging; imaging procedure; Imaging Procedures; Imaging, Not Otherwise Specified; Medical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of interest between the cutting planes	Will examine the volume of interest between the cutting planes that are determined by the anatomical landmarks around the eyebrows, ears and jaw that are manually identified from the three-dimensional (3D) surface scans. The volume of interest will be calculated for each 3D scan by a computer algorithm developed by Knockout Concepts. Test-rest reliability will be assessed by concordance correlation coefficients with 95% confidence interval by comparing two sets of volume of interest between repeated scans at each encounter. In addition, Bland-Altman plots with 95% Limits of Agreement will be reported for the bias between the two scoring systems.	Up to 24 weeks
Average values of the two repeated scans	Average values of the two repeated scans at each encounter will be plotted over the five clinical visits to graphically explore the trajectory of the change in the primary outcome.	Up to 24 weeks
Patient wellbeing/disease progression	Correlation between head and neck lymphedema and patient wellbeing/disease progression will be done by using linear regression, Pearson's correlation coefficient or spearman's correlation coefficient, depending on the distribution of the data.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Roman Skoracki, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): March 2, 2026

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Lymphatic Diseases; Lymphedema; Head and Neck Neoplasms; Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; X-Rays
• Other Study ID Numbers: OSU-20210; NCI-2020-08318 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No