Feasibility Study of MRI Imaging on Parotid Gland Stimulation
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility study of MRI imaging on parotid gland stimulation.
研究概览
简要总结
The aim of this study is to determine the feasibility of demonstrating the following physiologically-descriptive quantities ('metrics'): the volume of plasma/volume of tissue (νp), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space per volume of tissue (νe), and the contrast agent transfer coefficients (Ktrans) pre and post parotid stimulation in 10 healthy volunteers. Feasibility will be defined as 80% of volunteers achieving detectable signal changes in pre/post salivary MR images.
详细描述
OBJECTIVES
Primary Objective:
Feasibility will be defined as 80% of volunteers achieving detectable signal changes in pre/post salivary MR images (in either the IVIM or the DCE scans).
BACKGROUND INFORMATION AND RATIONALE
It is well known that loss of salivary function in the parotid glands leads to an elevated risk of chronically dry-mouth. Xerostomia is thought to result from salivary function loss due to damage of the functional aspects of the (saliva-producing) parotid gland, but the precise nature is unknown. Recent reports have found regional dose susceptibility in rat parotid(1); delivering dose to one region of the parotid results in a different incidence of xerostomia than would that same dose to another region. Similarly, regional dose susceptibility of subjective xerostomia (i.e. patient-reported) has been noted in human parotid(2). It is presently unclear to what extent these findings relate to objective functional loss, recovery, or xerostomia in humans. With this motivation, the investigators launched a preliminary project to search for changes of parotid salivary function resulting from irradiation during treatment for head-and-neck cancers. The Investigators hypothesis was that certain regions of the parotid are more susceptible to radiation damage than others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Age ≥ 18 Healthy normal volunteer
排除标准
- •Pregnant women Scheduled to take unusual or uncommon chemotherapy agents or medication Previous or about to undertake a course of radiotherapy Previous surgery to neck such as a lymph node dissection. Must not have, or be willing to replace, metal fillings or other foreign objects which will seriously impede image collection or analysis.
- •No contraindication to an MRI
结局指标
主要结局
Feasibility study of MRI imaging on parotid gland stimulation.
时间窗: time to recruit 10 healthy volunteers (approximately 4 months)
Feasibility will be defined as 80% of volunteers achieving detectable signal changes in pre/post salivary stimulation MR images. The following physiologically-descriptive quantities ('metrics') will be measured: the volume of plasma/volume of tissue (νp), Apparent Diffusion Coefficient (ADC), the volume of extracellular extravascular space per volume of tissue (νe), and the contrast agent transfer coefficients (Ktrans) pre and post parotid stimulation.
次要结局
未报告次要终点