This trial is completed!
Search for a recruiting clinical trial for your condition
Your journey
1What's a trial
2Find
3Review
4Get in touch
More info
You can access this
clinical trial
if you have
Autoimmune Diseases
and you are
over 30
years old
-
The phase for this study is not defined.
Show me locations

The purpose

This is a pilot imaging study to determine whether molecular imaging with 18^F fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT), 11^C-Methionine (MET) PET/CT, and salivary gland magnetic resonance imaging (MRI) with Dotarem (gadoterate meglumine) have the potential to characterize and quantify disease manifestations in primary Sjögren's syndrome (pSS) subjects. This will be achieved by assessing the associations and consistency between the imaging techniques studied, clinical assessments (salivary and tear flow and clinical scores), laboratory biomarkers, and histological findings on minor salivary gland biopsy. In this study, healthy volunteers will be enrolled in Group A and pSS subjects in Group B. The subjects will be required to undergo screening and baseline assessments including unstimulated and stimulated salivary flow and Schirmer's test; an imaging visit (Visit 1); a sample collection visit (Visit 2) for repeat of selected baseline assessments and a minor salivary gland biopsy for pSS subjects only; and a follow-up visit. The total duration of participation in the study will be up to 11 weeks.

Provided treatments

  • Radiation: 18F-FDG PET/CT Imaging
  • Radiation: 11C-MET PET/CT Imaging
  • Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine
  • Procedure: Minor Salivary gland (labial) biopsy

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02899377. The sponsor of the trial is GlaxoSmithKline and it is looking for 25 volunteers for the current phase.
Official trial title:
A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome