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OpenTrials
Completed

NCT Number: NCT05243069

Head and Neck Cancer Patient Symptom and Oncologic Outcomes

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.

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Key information

Conditions

Lymphedema of the Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imaging Technique

Procedure

Undergo 3D scanning

Other names: Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, Imaging, Not Otherwise Specified, Medical Imaging

Primary outcomes

  1. Volume of interest between the cutting planes

    Time frame: Up to 24 weeks

    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.

  2. Average values of the two repeated scans

    Time frame: Up to 24 weeks

    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.

  3. Patient wellbeing/disease progression

    Time frame: Up to 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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