Feasibility Study of MRI Imaging on Parotid Gland Stimulation

NCT02294838 | Unknown

• 1 other identifier: BCCA H14-02236
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parotid Neoplasms

Outcome Measures

Primary Outcomes (1)

• Feasibility study of MRI imaging on parotid gland stimulation.

  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.

  time to recruit 10 healthy volunteers (approximately 4 months)

Study Arms (1)

MRI with parotid gland stimulation

EXPERIMENTAL

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; Other: Citric acid; Other: Gadovist

Interventions

MRI DEVICE

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.

Also known as: Magnetic resonance imaging

MRI with parotid gland stimulation

Citric acid OTHER

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.

MRI with parotid gland stimulation

Gadovist OTHER

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.

MRI with parotid gland stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 Healthy normal volunteer

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, V5Z4E6, Canada

Location

Related Publications (2)

• van Luijk P, Faber H, Schippers JM, Brandenburg S, Langendijk JA, Meertens H, Coppes RP. Bath and shower effects in the rat parotid gland explain increased relative risk of parotid gland dysfunction after intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2009 Jul 15;74(4):1002-5. doi: 10.1016/j.ijrobp.2009.03.039.

  PMID: 19545785 BACKGROUND

• Buettner F, Miah AB, Gulliford SL, Hall E, Harrington KJ, Webb S, Partridge M, Nutting CM. Novel approaches to improve the therapeutic index of head and neck radiotherapy: an analysis of data from the PARSPORT randomised phase III trial. Radiother Oncol. 2012 Apr;103(1):82-7. doi: 10.1016/j.radonc.2012.02.006. Epub 2012 Mar 21.

  PMID: 22444242 BACKGROUND

MeSH Terms

Conditions

Parotid Neoplasms

Interventions

Magnetic Resonance Imaging; Citric Acid; gadobutrol

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jonn Wu

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 19, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2017
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

CA (1)