Head and Neck Cancer Patient Symptom and Oncologic Outcomes

NCT05243069 | Completed DMC

• 2 other identifiers: OSU-20210NCI-2020-08318
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema of the Head and Neck

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Screening (3D scan)

EXPERIMENTAL

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

Interventions

Imaging Technique PROCEDURE

Undergo 3D scanning

Also known as: Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, Imaging, Not Otherwise Specified, Medical Imaging

Screening (3D scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Roman Skoracki, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 16, 2022
• Study Start: March 31, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)