Clinical Trial: Feasibility Study of MRI Imaging on Parotid Gland Stimulation
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Feasibility Study of MRI Imaging on Parotid Gland Stimulation
Brief Summary: 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.
Detailed Summary:
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.
To test this hypothesis, data collected prospectively from one-hundred patients who underwent head-and-neck cancer treatment was analyzed for correlation between regional dose and salivary function response. Three-dimensional dose distributions were harvested from patient dose data and organ contours sub- segmented into a variety of regional "pieces". Sub-segmentation was guided by clinical re
Sponsor: British Columbia Cancer Agency
Current Primary Outcome: Feasibility study of MRI imaging on parotid gland stimulation. [ Time Frame: time to recruit 10 healthy volunteers (approximately 4 months) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: British Columbia Cancer Agency
Dates:
Date Received: November 12, 2014
Date Started: December 2014
Date Completion: February 2017
Last Updated: November 25, 2016
Last Verified: November 2016
