A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS Pts

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

November 18, 2016

Primary Completion Date

July 12, 2018

Study Completion Date

July 12, 2018

Conditions
Autoimmune Diseases
Interventions
RADIATION

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

RADIATION

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"

PROCEDURE

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.

PROCEDURE

Minor Salivary gland (labial) biopsy

A minor salivary gland biopsy will be performed at Visit 2 for pSS subjects only.

Trial Locations (4)

CB2 0GG

GSK Investigational Site, Cambridge

E1 4DG

GSK Investigational Site, London

NW1 2PG

GSK Investigational Site, London

Unknown

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY