Autoimmune Diseases Clinical Trial
Official title:
A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome
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.
n/a
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