Feasibility Study of MRI Imaging on Parotid Gland Stimulation (SPIT)
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|ClinicalTrials.gov Identifier: NCT02294838|
Recruitment Status : Unknown
Verified November 2016 by British Columbia Cancer Agency.
Recruitment status was: Active, not recruiting
First Posted : November 19, 2014
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Parotid Neoplasms||Device: MRI Other: Citric acid Other: Gadovist||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of MRI Imaging on Parotid Gland Stimulation|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||February 2017|
Experimental: MRI with parotid gland stimulation
All participants will have MRI imaging of the parotid gland with IV Gadovist pre and post parotid stimulation with lemon juice. 0.05 ml/kg of Gadovist (at 4 ml/s) and 20 ml of saline flush (also at 4 ml/s) will be administered. Approximately three minutes after scan commencement, the salivary glands will be stimulated by orally administering a small portion (≈5 ml) of Citric acid.
Participants will undergo MR imaging of the parotid gland pre and post stimulation. Perfusion images will be acquired using a time-resolved, spoiled GE sequence with 1×1×2 mm spatial resolution, approximately one second 3D temporal resolution, and image technique/contrast parameters TR = 2.8 ms and TE = 0.9 ms.
Other Name: Magnetic resonance imaging
Other: Citric acid
5 mls of 2% citric Acid will be delivered to the oral cavity via a syringe and Tygon tubing at two separate time intervals in order to stimulate the parotid gland during the MRI scanning process.
Upon commencement of the scan, 0.05 ml/kg of Gadovist (at 4 ml/s) and 20 ml of saline flush (also at 4 ml/s) will be administered.
- Feasibility study of MRI imaging on parotid gland stimulation. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294838
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z4E6|
|Principal Investigator:||Jonn Wu||British Columbia Cancer Agency|