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

Summary

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.

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.

Sponsors & Collaborators

• Quintiles, Inc.

  collaborator INDUSTRY

• GlaxoSmithKline

  lead INDUSTRY

Principal Investigators

• GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-11-18

Primary Completion

2018-07-12

Completion

2018-07-12

Countries

• United Kingdom

Study Locations