Head and Neck Cancer Patient Symptom and Oncologic Outcomes as a Function of Head and Neck Volume Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Volume of interest between the cutting planes
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Any health conditions or history of non-compliance that affect the study will preclude study participation
研究组 & 干预措施
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.
干预措施: Imaging Technique (Procedure)
结局指标
主要结局
Volume of interest between the cutting planes
时间窗: 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.
Average values of the two repeated scans
时间窗: 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.
Patient wellbeing/disease progression
时间窗: 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.
次要结局
未报告次要终点
研究者
Roman Skoracki
Principal Investigator
Ohio State University Comprehensive Cancer Center