Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility Study of MRI Imaging on Parotid Gland Stimulation (SPIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

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.

Condition or disease Intervention/treatment Phase
Parotid Neoplasms Device: MRI Other: Citric acid Other: Gadovist Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: MRI
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.

Other: Gadovist
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age ≥ 18 Healthy normal volunteer

Exclusion Criteria:

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


Information from the National Library of Medicine

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


Locations
Layout table for location information
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Layout table for investigator information
Principal Investigator: Jonn Wu British Columbia Cancer Agency

Publications:
Layout table for additonal information
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02294838     History of Changes
Other Study ID Numbers: BCCA H14-02236
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Parotid Neoplasms
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Parotid Diseases
Salivary Gland Diseases
Sodium Citrate
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action