25
Participants
Start Date
November 18, 2016
Primary Completion Date
July 12, 2018
Study Completion Date
July 12, 2018
18F-FDG PET/CT Imaging
pSS subjects (in fasting conditions) will receive one-time bolus IV injection of 200 MBq of 18F-FDG. After 60 minutes of administration, a PET scan will be performed with static scanning acquired for up to 30 to 40 minutes.Other name: 18F-FDG
11C-MET PET/CT Imaging
"Subjects (post meal) will receive one-time bolus IV injection of 500 MBq of 11C-MET. This will be followed by PET scan and dynamic scanning of the salivary gland region for approximately 40 minutes. A static scan will then be performed (within 5 minutes) with the whole body CT followed by the PET covering the head to hip with a duration of same range for approximately 20 to 30 minutes.~Other Name:11C-MET"
MRI Imaging with intravenous contrast with gadoterate meglumine
Eligible subjects will receive a one-time IV injection of 0.1mmol/kg of gadoterate meglumine followed by a multi-parametric MRI scanning.
Minor Salivary gland (labial) biopsy
A minor salivary gland biopsy will be performed at Visit 2 for pSS subjects only.
GSK Investigational Site, Cambridge
GSK Investigational Site, London
GSK Investigational Site, London
GSK Investigational Site, London
Lead Sponsor
Quintiles, Inc.
INDUSTRY
GlaxoSmithKline
INDUSTRY