Clinical trial · Interventional
Feasibility Study of MRI Imaging on Parotid Gland Stimulation
NCT02294838CI-TRIAL-00024916SPITunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parotid Neoplasms | Parotid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Citric acid | Other | — | UNRESOLVED |
| Gadovist | Other | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI with parotid gland stimulation
- description
- 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.
- interventionNames
- Device: MRI
- Other: Citric acid
- Other: Gadovist
Primary outcomes (1)
- measure
- Feasibility study of MRI imaging on parotid gland stimulation.
- timeFrame
- time to recruit 10 healthy volunteers (approximately 4 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDvan 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
- BACKGROUNDBuettner 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