Head and Neck Cancer Patient Symptom and Oncologic Outcomes
Primary Purpose
Lymphedema of the Head and Neck
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaging Technique
Sponsored by
About this trial
This is an interventional screening trial for Lymphedema of the Head and Neck
Eligibility Criteria
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
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening (3D scan)
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05243069
First Posted
February 24, 2021
Last Updated
February 7, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05243069
Brief Title
Head and Neck Cancer Patient Symptom and Oncologic Outcomes
Official Title
Head and Neck Cancer Patient Symptom and Oncologic Outcomes as a Function of Head and Neck Volume Changes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 31, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of the Head and Neck
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Screening (3D scan)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Imaging Technique
Other Intervention Name(s)
Diagnostic Imaging Technique, Imaging, imaging procedure, Imaging Procedures, Imaging, Not Otherwise Specified, Medical Imaging
Intervention Description
Undergo 3D scanning
Primary Outcome Measure Information:
Title
Volume of interest between the cutting planes
Description
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.
Time Frame
Up to 24 weeks
Title
Average values of the two repeated scans
Description
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.
Time Frame
Up to 24 weeks
Title
Patient wellbeing/disease progression
Description
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.
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Skoracki
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Skoracki
Email
Roman.Skoracki@osumc.edu
First Name & Middle Initial & Last Name & Degree
Roman Skoracki
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
Learn more about this trial
Head and Neck Cancer Patient Symptom and Oncologic Outcomes
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