Autoimmune DiseasesNCT02899377

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

A study testing 18F-FDG PET/CT Imaging, 11C-MET PET/CT Imaging and MRI Imaging with intravenous contrast with gadoterate meglumine in people with Autoimmune Diseases, run by GlaxoSmithKline at 4 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for: Autoimmune Diseases
What is being tested?: 18F-FDG PET/CT Imaging, 11C-MET PET/CT Imaging and MRI Imaging with intravenous contrast with gadoterate meglumine
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 4 sitesUnited Kingdom
Study dates: 18 Nov 2016to 12 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

GROUP A: Healthy Volunteers Subjects for both PET/CT and MRI: Aged >=40 years inclusive at the time of signing the informed consent.
Subjects for MRI, without PET/CT: Aged >=30 years inclusive at the time of signing the informed consent Healthy as defined by the investigator, or medically qualified designee, based on a medical evaluation including medical history, physical examination, and laboratory tests.
Group B: Primary Sjögren's Syndrome Patients Age >=30 years, at the time of signing the informed consent. Diagnosis of pSS according to the American-European Consensus Group criteria Baseline unstimulated salivary flow >0.0 mL/min or evidence of glandular reserve function (stimulated baseline salivary flow >0.05 mL/min).
Systemically active disease, ESSDAI >=5 points
All Subjects Body weight >=50 kilogram (kg) and body mass index within the range 18.5 to 35 kg/m^2 (inclusive)
Male or Female, where one of the following conditions apply:
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin test) at screening, and a negative urine pregnancy test 4-7 days prior to Visit 1, on the day of Visit 1 (on each day of scanning), on Visit 2, is not lactating, and at least one of the following conditions applies: non-reproductive potential or reproductive potential and agrees to use contraceptive methods listed in the protocol from 28 days prior to Visit 1 until follow up.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.

Who cannot join

Diagnosis of secondary Sjögren's Syndrome.
Diagnosis of another systemic autoimmune disease, apart from pSS, including but not limited to, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis or systemic vasculitis. For Group B subjects, autoimmune conditions associated with pSS (for example autoimmune thyroiditis, primary biliary cirrhosis or coeliac disease), are not included in this exclusion, but should be described in the medical history taken baseline. If in doubt please consult the medical monitor.
Subjects with active life-threatening or organ-threatening effects of pSS meaning that they may not be able to complete the study visits according to the protocol (as determine by the investigator) (Group B).
History of coagulation or bleeding disorders which would increase the risk of minor salivary gland biopsy (for example, but not limited to, Hemophilia A or B, Von Willibrand's disease, platelet function disorders; Group B).
History of malignancy within 5 years of screening that, in the view of the investigator, in consultation with the medical monitor if required, could confound the results of the 18F-FDG PET/CT scan (including lymphoma associated with pSS). This does not include cervical carcinoma in situ or non-melanoma skin malignancy that has been treated with curative surgical treatment.
History of unresolved acute or chronic infection that, in the view of the investigator in consultation with the medial monitor, if required, could confound the results of the 18F-FDG PET/CT.

Show all 22Show fewer

Subject with diabetes mellitus requiring insulin therapy
Contraindications to MRI scanning (as assessed by MRI safety questionnaire).
History of, or suffers from, claustrophobia or feel that they will be unable to lie still in the PET or MRI scanner for a period of up to 1 to 2 hours.
Where participation in the study would result in donation of blood or blood products in excess of 500mL within a 56 day period.
Previous inclusion in a research protocol involving nuclear medicine, PET or radiological investigations, or as a result of occupational exposure with a significant radiation burden (a significant radiation burden being defined as 10mSv in addition to natural background radiation, in the previous 3 years including the dose from this study). A clinical procedure where the subject received a direct benefit (eg diagnostic test) will not be included in the calculation of exposure.
Lack of adequate peripheral venous access for cannulation.
Current participation in a study with an investigational product, or recent participation within 5 half lives of discontinuation the drug, or within twice the duration of the biological effect of the drug, whichever is longer
Group A: Healthy volunteers Subject is unable to refrain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days prior to Visit 1 until completion of Visit 2, unless in the opinion of the investigator and Sponsor the medication will not interfere with the study.
Group B: pSS subjects taking immunomodulatory treatment at screening are excluded unless they have been on stable doses of these medicines for 6 weeks prior to Screening/Baseline and are expected to remain on stable doses of these medications until the Follow up visit. This would include drugs such as glucocorticoids, immunosuppressive agents (for example, hydroxychloroquine, azathioprine, methotrexate, mycophenolate mofetil, and biologic therapies). If in doubt, to be discussed with the Medical Monitor.
Group B: pSS subjects receiving treatment with anti-coagulant medications, including but not limited to warfarin, heparin, thrombin inhibitors, and Factor Xa inhibitors, and aspirin, unless the subjects is able to discontinue these medications one week prior to minor salivary gland biopsy, or according to local guidelines. The treatment may be restarted 3 days after the biopsy, or according to local guidelines.
History of alcohol, prescription or non-prescription drug abuse which could interfere with participation in the trial according to the protocol, or in the opinion of the investigator impacts on the physical or mental wellbeing of the subject
History of allergy/hypersensitivity to study medications including local anesthesia (Group B), radio-isotopes or gadolinium-containing contrast agents (all subjects).
Contraindications to gadolinium-containing contrast agents in accordance with product labeling and local guidelines
Estimated GFR (Modification of Diet in Renal Disease calculation) of less than 60 mL/min/1.73m^2 at screening.
Platelet count below the laboratory normal range at screening, or prothrombin time above the laboratory normal range at screening (Group B).
Subject with a fasting blood sugar >11.1 millimoles (mmol)/Liters (L) at screening (defined as fasting for a minimum of 6 hours, excluding unflavored water).

Trial locations and contacts

4 sites in 1 country.

United Kingdom4 sites

GSK Investigational Site
Cambridge, CB2 0GG
GSK Investigational Site
London, E1 4DG
GSK Investigational Site
London, NW1 2PG
GSK Investigational Site
London

Other trials in United Kingdom

About this study

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.

Conditions: Autoimmune Diseases
Being tested: 18F-FDG PET/CT Imaging, 11C-MET PET/CT Imaging, MRI Imaging with intravenous contrast with gadoterate meglumine, Minor Salivary gland (labial) biopsy
Keywords: PET/CT, Primary Sjögren's Syndrome, Magnetic resonance imaging, 11^C-MET, 18^F-FDG
Medical subject headings: Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

18F-FDG PET/CT ImagingRadiation
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 ImagingRadiation
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 meglumineProcedure or surgery
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) biopsyProcedure or surgery
A minor salivary gland biopsy will be performed at Visit 2 for pSS subjects only.

Study groups in NCT02899377
Study group	Role	What they receive
Group A: Health subjects	Experimental	During Visit 1, these subjects will undergo the following: An MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 mmol/kg of gadoterate meglumine and receive one-time IV bolus injection of 500 megabecquerels (MBq) of 11C MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan) Receives: Radiation: 11C-MET PET/CT Imaging; Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine
Group B: pSS subjects	Experimental	During Visit 1, subjects with pSS will undergo the following: An MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and receive one-time IV bolus injections: 500 MBq of 11C-MET (PET/CT: as for Group A) and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan) Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas
Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, pancreas, lumbar vertebra, salivary gland, spleen, and thyroid. Safety Population included all participants who underwent any procedure on or after Visit 1.
Measured: Visit 1: Within 6 weeks after Baseline
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which is left and right region combined value has been reported for the regions of interest. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time.
Measured: Visit 1: Within 6 weeks after Baseline
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for the following selected body areas: aorta, liver, lumbar vertebra, muscle, pancreas, salivary gland, spleen, and thyroid.
Measured: Visit 1: Within 6 weeks after Baseline
TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.
Measured: Visit 1: Within 6 weeks after Baseline
Total Inflammatory Volume for 18F- FDG for pSS Participants at Selected Body Areas
There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV
Measured: Visit 1: Within 6 weeks after Baseline
SUV for 11C- MET in Selected Body Areas
Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan is reported.
Measured: Visit 1: Within 6 weeks after Baseline
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time.
Measured: Visit 1: Within 6 weeks after Baseline
TR Ratio for 11C- MET
Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan has been reported.
Measured: Visit 1: Within 6 weeks after Baseline
TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland
Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.
Measured: Visit 1: Within 6 weeks after Baseline
Total Inflammatory Volume 11C- MET at Selected Body Areas
There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV.
Measured: Visit 1: Within 6 weeks after Baseline
Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)
Quantitative parameters like ADC assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and interquartile range (IQR) values for ADC was used for analysis. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.
Measured: Visit 1: Within 6 weeks after Baseline
Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)
Quantitative parameters like pure D assessed the use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values for pure D was used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported.
Measured: Visit 1: Within 6 weeks after Baseline
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Quantitative parameters like Microvascular Volume Fraction assessed use of multi-parametric MRI in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported. The IVIM (intra-voxel incoherent motion) model estimates two separate pools of diffusion (for a microvascular component and a tissue component). Pool one describes fraction (f) of the signal. Pool two describes fraction (1-f) of the signal. Microvascular Volume Fraction (f) is the ratio of the signal contribution of the microvascular pool (pool one) over the entire signal.
Measured: Visit 1: Within 6 weeks after Baseline
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Quantitative parameters like KTrans assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported.
Measured: Visit 1: Within 6 weeks after Baseline

Secondary outcomes (2)

Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Blood samples were collected at indicated time points for radio-pharmacokinetic analysis of Ki. Pharmacokinetic (PK) Population included those participants in the 'Safety' population for whom a radio-pharmacokinetic sample was obtained and analyzed. Data for lower value of region (low), higher value of region (high) and right-left combined values (aggregated) is presented.
Measured: 0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Blood samples were collected at indicated time points for analysis. Pearson's correlation is presented along with 95% confidence interval.
Measured: 0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 201612 Jul 2018

First posted14 Sep 2016 (estimated)
Study start18 Nov 2016
Primary completion12 Jul 2018
Study completion12 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02899377
Sponsor's protocol ID: 203818
Status last verified: Oct 2019
First submitted: 23 Aug 2016
Last updated: 25 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome
ClinicalTrials.gov ID: NCT02899377
Acronym / sponsor ID: 203818
Conditions: Autoimmune Diseases
Keywords: PET/CT, Primary Sjögren's Syndrome, Magnetic resonance imaging, 11^C-MET, 18^F-FDG
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Quintiles, Inc.
Study start: 18 Nov 2016 (actual)
Primary completion: 12 Jul 2018 (actual)
Study completion: 12 Jul 2018 (actual)
First posted: 14 Sep 2016 (estimated)
Results: Posted 25 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A: Health subjects	Experimental	Radiation: 11C-MET PET/CT Imaging, Procedure: MRI Imaging with intravenous contrast with gadoterate meglumineDuring Visit 1, these subjects will undergo the following: An MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 mmol/kg of gadoterate meglumine and receive one-time IV bolus injection of 500 megabecquerels (MBq) of 11C MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
Group B: pSS subjects	Experimental	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) biopsyDuring Visit 1, subjects with pSS will undergo the following: An MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and receive one-time IV bolus injections: 500 MBq of 11C-MET (PET/CT: as for Group A) and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan)

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

GROUP A: Healthy Volunteers Subjects for both PET/CT and MRI: Aged >=40 years inclusive at the time of signing the informed consent.
Subjects for MRI, without PET/CT: Aged >=30 years inclusive at the time of signing the informed consent Healthy as defined by the investigator, or medically qualified designee, based on a medical evaluation including medical history, physical examination, and laboratory tests.
Group B: Primary Sjögren's Syndrome Patients Age >=30 years, at the time of signing the informed consent. Diagnosis of pSS according to the American-European Consensus Group criteria Baseline unstimulated salivary flow >0.0 mL/min or evidence of glandular reserve function (stimulated baseline salivary flow >0.05 mL/min).
Systemically active disease, ESSDAI >=5 points
All Subjects Body weight >=50 kilogram (kg) and body mass index within the range 18.5 to 35 kg/m^2 (inclusive)

Key exclusion criteria (22 listed)

Diagnosis of secondary Sjögren's Syndrome.
Diagnosis of another systemic autoimmune disease, apart from pSS, including but not limited to, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis or systemic vasculitis. For Group B subjects, autoimmune conditions associated with pSS (for example autoimmune thyroiditis, primary biliary cirrhosis or coeliac disease), are not included in this exclusion, but should be described in the medical history taken baseline. If in doubt please consult the medical monitor.
Subjects with active life-threatening or organ-threatening effects of pSS meaning that they may not be able to complete the study visits according to the protocol (as determine by the investigator) (Group B).
History of coagulation or bleeding disorders which would increase the risk of minor salivary gland biopsy (for example, but not limited to, Hemophilia A or B, Von Willibrand's disease, platelet function disorders; Group B).
History of malignancy within 5 years of screening that, in the view of the investigator, in consultation with the medical monitor if required, could confound the results of the 18F-FDG PET/CT scan (including lymphoma associated with pSS). This does not include cervical carcinoma in situ or non-melanoma skin malignancy that has been treated with curative surgical treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
18F-FDG PET/CT ImagingpSS 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	Group B: pSS subjects
11C-MET PET/CT ImagingSubjects (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	Radiation	Group A: Health subjects, Group B: pSS subjects
MRI Imaging with intravenous contrast with gadoterate meglumineEligible subjects will receive a one-time IV injection of 0.1mmol/kg of gadoterate meglumine followed by a multi-parametric MRI scanning.	Procedure or surgery	Group A: Health subjects, Group B: pSS subjects
Minor Salivary gland (labial) biopsyA minor salivary gland biopsy will be performed at Visit 2 for pSS subjects only.	Procedure or surgery	Group B: pSS subjects

Primary outcome

Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, pancreas, lumbar vertebra, salivary gland, spleen, and thyroid. Safety Population included all participants who underwent any procedure on or after Visit 1.
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which is left and right region combined value has been reported for the regions of interest. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time.
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for the following selected body areas: aorta, liver, lumbar vertebra, muscle, pancreas, salivary gland, spleen, and thyroid.
TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.
Total Inflammatory Volume for 18F- FDG for pSS Participants at Selected Body Areas
Time frame: Visit 1: Within 6 weeks after Baseline
There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV
SUV for 11C- MET in Selected Body Areas
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan is reported.
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time.
TR Ratio for 11C- MET
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan has been reported.
TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland
Time frame: Visit 1: Within 6 weeks after Baseline
Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.
Total Inflammatory Volume 11C- MET at Selected Body Areas
Time frame: Visit 1: Within 6 weeks after Baseline
There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV.
Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)
Time frame: Visit 1: Within 6 weeks after Baseline
Quantitative parameters like ADC assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and interquartile range (IQR) values for ADC was used for analysis. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.
Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)
Time frame: Visit 1: Within 6 weeks after Baseline
Quantitative parameters like pure D assessed the use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values for pure D was used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported.
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Time frame: Visit 1: Within 6 weeks after Baseline
Quantitative parameters like Microvascular Volume Fraction assessed use of multi-parametric MRI in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported. The IVIM (intra-voxel incoherent motion) model estimates two separate pools of diffusion (for a microvascular component and a tissue component). Pool one describes fraction (f) of the signal. Pool two describes fraction (1-f) of the signal. Microvascular Volume Fraction (f) is the ratio of the signal contribution of the microvascular pool (pool one) over the entire signal.
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Time frame: Visit 1: Within 6 weeks after Baseline
Quantitative parameters like KTrans assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported.

2 secondary outcomes

Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Time frame: 0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Time frame: 0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection

Results and safety

Results posted to the registry on 25 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants	13	12
Participants With pSS	12	12

Primary outcome: Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas

Time frame: Visit 1: Within 6 weeks after Baseline. Mean (Standard Deviation). Unit: Grams per milliliter

Measure	Participants With pSS n = 12
Aorta, Max SUV	2.9067 (0.49445)
Liver, Max SUV	5.0683 (1.13564)
Lumbar Vertebra, Max SUV	4.0225 (0.91105)
Muscle, Max SUV	1.4558 (0.50282)
Pancreas, Max SUV	4.2700 (1.02711)
Salivary gland, Max SUV	3.1067 (0.83496)
Spleen, Max SUV	3.2333 (0.54135)
Thyroid, Max SUV	3.1408 (0.72742)

Population analysed: Safety Population

Primary outcome: SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants

Time frame: Visit 1: Within 6 weeks after Baseline. Mean (Standard Deviation). Unit: Grams per milliliter

Measure	Participants With pSS n = 12
Lachrymal gland, Low, Max SUV	1.7808 (0.38311)
Lachrymal gland, High, Max SUV	2.0658 (0.34849)
Lachrymal gland, Aggregated, Max SUV	2.0658 (0.34849)
Parotid gland, Low, Max SUV	2.5767 (0.68672)
Parotid gland, High, Max SUV	2.7783 (0.76902)
Parotid gland, Aggregated, Max SUV	2.7783 (0.76902)
Submandibular gland, Low, Max SUV	2.5200 (0.82131)
Submandibular gland, High, Max SUV	2.9250 (0.94362)

Population analysed: Safety Population

Primary outcome: Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants

Time frame: Visit 1: Within 6 weeks after Baseline. Mean (Standard Deviation). Unit: Ratio

Measure	Participants With pSS n = 12
Aorta	1.0660 (0.05729)
Liver	1.7366 (0.11645)
Lumbar Vertebra	1.5096 (0.28568)
Muscle	0.4669 (0.10222)
Pancreas	1.4312 (0.16490)
Salivary gland	1.1730 (0.38592)
Spleen	1.2625 (0.17400)
Thyroid	1.2193 (0.44934)

Population analysed: Safety Population

Primary outcome: TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants

Time frame: Visit 1: Within 6 weeks after Baseline. Mean (Standard Deviation). Unit: Ratio

Measure	Participants With pSS n = 12
Lachrymal gland, Low	0.8529 (0.12250)
Lachrymal gland, High	0.9201 (0.13587)
Lachrymal gland, Aggregated	0.8864 (0.12560)
Parotid gland, Low	1.1158 (0.44262)
Parotid gland, High	1.2338 (0.47055)
Parotid gland, Aggregated	1.1749 (0.45273)
Submandibular gland, Low	1.0472 (0.43105)
Submandibular gland, High	1.2953 (0.41063)

Population analysed: Safety Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events and serious adverse events (SAE) were collected up to 11 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Participants	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Participants With pSS	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas (time frame: Visit 1: Within 6 weeks after Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02899377.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.