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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02899377
• Collaborator: Quintiles, Inc. (Industry)
• Enrollment: 25
• Locations: 4
• Arms: 2
• Actual Duration (Months): 19.7
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases	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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome
• Actual Study Start Date: Nov 18, 2016
• Actual Primary Completion Date: Jul 12, 2018
• Actual Study Completion Date: Jul 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: Health subjects 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)	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.
Experimental: Group B: pSS subjects 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)	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.

Outcome Measures

Primary Outcome Measures

1. Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas [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.

2. SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants [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.

3. Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants [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.

4. TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants [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.

5. Total Inflammatory Volume for 18F- FDG for pSS Participants at Selected Body Areas [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

6. SUV for 11C- MET in Selected Body Areas [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.

7. SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET [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.

8. TR Ratio for 11C- MET [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.

9. TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland [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.

10. Total Inflammatory Volume 11C- MET at Selected Body Areas [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.

11. Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) [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.

12. Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) [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.

13. Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction [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.

14. Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) [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.

Secondary Outcome Measures

1. Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT [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]

   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.

2. Correlation Between Static and Dynamic Imaging Metrics in 11C-MET [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]

   Blood samples were collected at indicated time points for analysis. Pearson's correlation is presented along with 95% confidence interval.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Cambridge		United Kingdom	CB2 0GG
2	GSK Investigational Site	London		United Kingdom	E1 4DG
3	GSK Investigational Site	London		United Kingdom	NW1 2PG
4	GSK Investigational Site	London		United Kingdom

Sponsors and Collaborators

• GlaxoSmithKline
• Quintiles, Inc.

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

• Study Protocol - May 24, 2017
• Statistical Analysis Plan - Jun 8, 2018

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02899377
• Other Study ID Numbers: 203818
• First Posted: Sep 14, 2016
• Last Update Posted: Oct 25, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: PET/CT; Primary Sjögren's Syndrome; Magnetic resonance imaging; 11^C-MET; 18^F-FDG
• Additional relevant MeSH terms: Sjogren's Syndrome; Autoimmune Diseases; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Study Results

Participant Flow

Recruitment Details	This was a pilot imaging study using positron emission tomography (PET)/computed tomography (CT) and multi parametric magnetic resonance imaging (MRI) to investigate the potential to characterize and quantify disease manifestation in primary Sjögren's syndrome (pSS) participants.
Pre-assignment Detail	A total of 25 participants were enrolled in the study. The study was conducted at 3 centers in the United Kingdom.

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 millimoles (mmol)/kilogram (kg) of gadoterate meglumine and received one-time IV bolus injection of 500 megabecquerels (MBq) of carbon11-methionine (11C -MET) followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-flurodeoxyglucose (FDG) followed by a PET/CT (static head to hip scan).
Period Title: Overall Study
STARTED	13	12
COMPLETED	12	12
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Healthy Participants	Participants With pSS	Total
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).	Total of all reporting groups
Overall Participants	13	12	25
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48.1 (13.87)	49.0 (13.70)	48.5 (13.51)
Sex: Female, Male (Count of Participants)
Female	13 100%	12 100%	25 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants) [Number]
Asian: Central/south Asian heritage	0 0%	3 25%	3 12%
Asian: South East Asian heritage	0 0%	1 8.3%	1 4%
Black or African American	2 15.4%	0 0%	2 8%
White/Caucasian/European Heritage	10 76.9%	5 41.7%	15 60%
Mixed race White Caribbean	1 7.7%	0 0%	1 4%
Unknown	0 0%	2 16.7%	2 8%
Black British	0 0%	1 8.3%	1 4%

Outcome Measures

1. Primary Outcome

Title	Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	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)
Aorta, Mean SUV	1.883 (0.2740)
Liver, Mean SUV	2.273 (0.2605)
Lumbar Vertebra, Mean SUV	2.105 (0.4000)
Muscle, Mean SUV	0.657 (0.1696)
Pancreas, Mean SUV	1.874 (0.2511)
Spleen, Mean SUV	1.751 (0.1889)
Thyroid, Mean SUV	1.822 (0.5509)
Aorta, Peak SUV	2.0125 (0.35028)
Liver, Peak SUV	3.2700 (0.53533)
Lumbar Vertebra, Peak SUV	2.8242 (0.58906)
Muscle, Peak SUV	0.8833 (0.25378)
Pancreas, Peak SUV	2.6892 (0.47389)
Salivary gland, Peak SUV	2.1425 (0.58856)
Spleen, Peak SUV	2.3475 (0.30266)
Thyroid, Peak SUV	2.2458 (0.68193)

2. Primary Outcome

Title	SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	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)
Submandibular gland, Aggregated, Max SUV	2.9250 (0.94362)
Lachrymal gland, Low, Mean SUV	1.311 (0.3218)
Lachrymal gland, High, Mean SUV	1.515 (0.2934)
Parotid gland, Low, Mean SUV	1.620 (0.5022)
Parotid gland, High, Mean SUV	1.818 (0.5957)
Submandibular gland, Low, Mean SUV	1.709 (0.6786)
Submandibular gland, High, Mean SUV	1.916 (0.6237)
Lachrymal gland, Low, Peak SUV	1.5842 (0.18535)
Lachrymal gland, High, Peak SUV	1.7125 (0.24264)
Lachrymal gland, Aggregated, Peak SUV	1.6492 (0.20505)
Parotid gland, Low, Peak SUV	2.0150 (0.64590)
Parotid gland, High, Peak SUV	2.2383 (0.71837)
Parotid gland, Aggregated, Peak SUV	2.1275 (0.67216)
Submandibular gland, Low, Peak SUV	1.9275 (0.74620)
Submandibular gland, High, Peak SUV	2.3883 (0.69049)
Submandibular gland, Aggregated, Peak SUV	2.1583 (0.67168)

3. Primary Outcome

Title	Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	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)

4. Primary Outcome

Title	TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	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)
Submandibular gland, Aggregated	1.1711 (0.40012)

5. Primary Outcome

Title	Total Inflammatory Volume for 18F- FDG for pSS Participants at Selected Body Areas
Description	There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected

Arm/Group Title	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	0

6. Primary Outcome

Title	SUV for 11C- MET in Selected Body Areas
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	Participants With pSS	Healthy Participants
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
Measure Participants	12	8
Aorta, Max SUV	2.2700 (0.72709)	2.0275 (0.62609)
Liver, Max SUV	19.1667 (3.81783)	16.4213 (3.31237)
Lumbar Vertebra, Max SUV	7.1733 (2.85382)	5.9100 (1.43376)
Muscle, Max SUV	2.4167 (0.89879)	2.3513 (1.01454)
Pancreas, Max SUV	31.4492 (5.17911)	31.7388 (5.68871)
Salivary gland, Max SUV	5.4275 (1.43053)	6.6900 (1.05224)
Spleen, Max SUV	5.5100 (1.35700)	5.2750 (1.22413)
Thyroid, Max SUV	3.7058 (0.86450)	3.1038 (0.79784)
Aorta, Mean SUV	1.161 (0.2927)	1.029 (0.3334)
Liver, Mean SUV	10.926 (2.1692)	8.916 (1.4380)
Lumbar Vertebra, Mean SUV	3.485 (0.9351)	2.923 (0.5387)
Muscle, Mean SUV	0.968 (0.2074)	0.926 (0.2365)
Pancreas, Mean SUV	16.413 (3.1008)	16.556 (2.9023)
Spleen, Mean SUV	2.650 (0.3745)	2.423 (0.1005)
Thyroid, Mean SUV	2.149 (0.6418)	1.646 (0.3138)
Aorta, Peak SUV	1.3250 (0.37590)	1.1338 (0.41008)
Liver, Peak SUV	14.7808 (3.01666)	12.3438 (1.76812)
Lumbar Vertebra, Peak SUV	4.7317 (1.28105)	3.8775 (0.62923)
Muscle, Peak SUV	1.3675 (0.40656)	1.3100 (0.29544)
Pancreas, Peak SUV	26.4683 (4.29608)	26.7913 (6.21700)
Salivary gland, Peak SUV	3.3633 (1.16624)	5.0600 (0.83111)
Spleen, Peak SUV	3.6975 (0.61556)	3.4100 (0.35633)
Thyroid, Peak SUV	2.6000 (0.65448)	2.0525 (0.29673)

7. Primary Outcome

Title	SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	Participants With pSS	Healthy Participants
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
Measure Participants	12	8
Lachrymal gland, Low, Max SUV	1.9133 (1.00469)	2.5513 (1.00049)
Lachrymal gland, High, Max SUV	2.1483 (1.02205)	3.1250 (1.49196)
Lachrymal gland, Aggregated, Max SUV	2.1483 (1.02205)	3.1250 (1.49196)
Parotid gland, Low, Max SUV	4.3933 (1.31072)	5.9038 (1.01547)
Parotid gland, High, Max SUV	4.9492 (1.22415)	6.3750 (1.09929)
Parotid gland, Aggregated, Max SUV	4.9492 (1.22415)	6.3750 (1.09929)
Submandibular gland, Low, Max SUV	3.8583 (1.78484)	6.2150 (1.06158)
Submandibular gland, High, Max SUV	4.4692 (1.77872)	6.5488 (0.94266)
Submandibular gland, Aggregated, Max SUV	4.4692 (1.77872)	6.5488 (0.94266)
Lachrymal gland, Low, Mean SUV	1.312 (0.6048)	1.703 (0.5810)
Lachrymal gland, High, Mean SUV	1.462 (0.6490)	2.056 (0.7874)
Parotid gland, Low, Mean SUV	2.525 (0.8740)	3.505 (0.5637)
Parotid gland, High, Mean SUV	2.925 (0.8679)	3.648 (0.5709)
Submandibular gland, Low, Mean SUV	2.388 (1.1855)	3.923 (0.4941)
Submandibular gland, High, Mean SUV	2.648 (1.2128)	4.191 (0.5410)
Lachrymal gland, Low, Peak SUV	1.3525 (0.59715)	1.7738 (0.66125)
Lachrymal gland, High, Peak SUV	1.4958 (0.65626)	2.1688 (0.99580)
Lachrymal gland, Aggregated, Peak SUV	1.4233 (0.62222)	1.9713 (0.81354)
Parotid gland, Low, Peak SUV	3.4367 (1.22748)	4.9000 (0.92893)
Parotid gland, High, Peak SUV	3.9175 (1.18255)	5.1663 (0.85276)
Parotid gland, Aggregated, Peak SUV	3.6767 (1.18792)	5.0325 (0.89020)
Submandibular gland, Low, Peak SUV	2.8025 (1.53196)	4.8588 (0.86087)
Submandibular gland, High, Peak SUV	3.2992 (1.63167)	5.3100 (0.89113)
Submandibular gland, Aggregated, Peak SUV	3.0517 (1.56359)	5.0838 (0.86490)

8. Primary Outcome

Title	TR Ratio for 11C- MET
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	Participants With pSS	Healthy Participants
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
Measure Participants	12	8
Aorta	1.1352 (0.06738)	1.0910 (0.04942)
Liver	13.1513 (3.13572)	12.8649 (3.46136)
Lumbar Vertebra	4.1158 (0.85314)	3.9731 (0.80867)
Muscle	1.1914 (0.26802)	1.3354 (0.34831)
Pancreas	23.5403 (4.62140)	29.8331 (15.21426)
Salivary gland	3.0974 (1.30105)	5.2805 (1.44642)
Spleen	3.2872 (0.67470)	3.5414 (0.81253)
Thyroid	2.3002 (0.63142)	2.1213 (0.49670)

9. Primary Outcome

Title	TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed

Arm/Group Title	Participants With pSS	Healthy Participants
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
Measure Participants	12	8
Lachrymal gland, Low	1.2007 (0.55639)	1.8219 (0.62711)
Lachrymal gland, High	1.3178 (0.59115)	2.1965 (0.76588)
Lachrymal gland, Aggregated	1.2594 (0.57188)	2.0094 (0.68084)
Parotid gland, Low	3.1810 (1.44525)	5.1570 (1.61371)
Parotid gland, High	3.6198 (1.41338)	5.4621 (1.73285)
Parotid gland, Aggregated	3.4003 (1.41542)	5.3096 (1.67006)
Submandibular gland, Low	2.5766 (1.61682)	5.0230 (1.20994)
Submandibular gland, High	3.0126 (1.61982)	5.4796 (1.30126)
Submandibular gland, Aggregated	2.7946 (1.60578)	5.2513 (1.24653)

10. Primary Outcome

Title	Total Inflammatory Volume 11C- MET at Selected Body Areas
Description	There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected

Arm/Group Title	Participants With pSS	Healthy Participants
Arm/Group Description	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
Measure Participants	0	0

11. Primary Outcome

Title	Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	13	12
Parotid Gland, Low, IQR, n=12, 11	0.511 (0.0314)	0.516 (0.0356)
Parotid Gland, High, IQR, n=12, 11	0.581 (0.0275)	0.646 (0.0412)
Parotid Gland, Aggregated, IQR, n=12, 11	0.544 (0.0264)	0.582 (0.0408)
Submandibular Gland, Low, IQR, n=12, 10	0.549 (0.0321)	0.765 (0.0693)
Submandibular Gland, High, IQR, n=12, 10	0.674 (0.0309)	0.928 (0.0714)
Submandibular Gland, Aggregated, IQR, n=12, 11	0.602 (0.0303)	0.809 (0.0695)
Parotid Gland, Low, Median, n=12, 11	1.091 (0.0476)	1.011 (0.0607)
Parotid Gland, High, Median, n=12, 11	1.153 (0.0451)	1.117 (0.0524)
Parotid Gland, Aggregated, Median, n=12, 11	1.120 (0.0460)	1.069 (0.0539)
Submandibular Gland, Low, Median, n=12, 10	1.469 (0.0377)	1.410 (0.0924)
Submandibular Gland, High, Median, n=12, 10	1.540 (0.0461)	1.551 (0.0833)
Submandibular Gland, Aggregated, Median, n=12, 11	1.506 (0.0396)	1.474 (0.0767)

12. Primary Outcome

Title	Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	13	12
Parotid Gland, Low, IQR, n=12, 11	0.437 (0.0343)	0.449 (0.0326)
Parotid Gland, High, IQR, n=12, 11	0.503 (0.0336)	0.529 (0.0296)
Parotid Gland, Aggregated, IQR, n=12, 11	0.468 (0.0344)	0.493 (0.0322)
Submandibular Gland, Low, IQR, n=12, 10	0.553 (0.0361)	0.547 (0.0440)
Submandibular Gland, High, IQR, n=12, 10	0.733 (0.0377)	0.681 (0.0641)
Submandibular Gland, Aggregated, IQR, n=12, 11	0.636 (0.0324)	0.608 (0.0443)
Parotid Gland, Low, Median, n=12, 11	0.771 (0.0269)	0.621 (0.0492)
Parotid Gland, High, Median, n=12, 11	0.807 (0.0287)	0.715 (0.0450)
Parotid Gland, Aggregated, Median, n=12, 11	0.787 (0.0274)	0.676 (0.0457)
Submandibular Gland, Low, Median, n=12, 10	0.941 (0.0445)	0.733 (0.0924)
Submandibular Gland, High, Median, n=12, 10	1.035 (0.0402)	0.814 (0.0887)
Submandibular Gland, Aggregated, Median, n=12, 11	0.993 (0.0409)	0.807 (0.0905)

13. Primary Outcome

Title	Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	13	12
Parotid Gland, Low, IQR, n=12, 11	0.135 (0.0084)	0.135 (0.0122)
Parotid Gland, High, IQR, n=12, 11	0.164 (0.0082)	0.172 (0.0155)
Parotid Gland, Aggregated, IQR, n=12, 11	0.149 (0.0090)	0.156 (0.0145)
Submandibular Gland, Low, IQR, n=12, 10	0.204 (0.0126)	0.205 (0.0101)
Submandibular Gland, High, IQR, n=12, 10	0.233 (0.0143)	0.233 (0.0102)
Submandibular Gland, Aggregated, IQR, n=12, 11	0.219 (0.0135)	0.217 (0.0097)
Parotid Gland, Low, Median, n=12, 11	0.131 (0.0068)	0.139 (0.0068)
Parotid Gland, High, Median, n=12, 11	0.151 (0.0098)	0.164 (0.0127)
Parotid Gland, Aggregated, Median, n=12, 11	0.140 (0.0079)	0.151 (0.0100)
Submandibular Gland, Low, Median, n=12, 10	0.198 (0.0164)	0.238 (0.0263)
Submandibular Gland, High, Median, n=12, 10	0.223 (0.0167)	0.271 (0.0257)
Submandibular Gland, Aggregated, Median, n=12, 11	0.210 (0.0165)	0.243 (0.0273)

14. Primary Outcome

Title	Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Description	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.
Time Frame	Visit 1: Within 6 weeks after Baseline

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	13	12
Parotid Gland, Low, IQR, n=12, 12	7.618 (3.8286)	22.492 (9.8803)
Parotid Gland, High, IQR, n=12, 12	12.821 (6.7497)	30.199 (13.2411)
Parotid Gland, Aggregated, IQR, n=12, 12	10.701 (5.5677)	27.213 (12.3396)
Submandibular Gland, Low, IQR, n=9, 8	5.548 (4.6510)	0.459 (0.0850)
Submandibular Gland, High, IQR, n=9, 8	15.192 (9.3625)	19.914 (17.5121)
Submandibular Gland, Aggregated, IQR, n=11, 11	10.191 (6.1313)	1.801 (0.8246)
Parotid Gland, Low, Median, n=12, 12	5.598 (2.5910)	3.326 (1.3677)
Parotid Gland, High, Median, n=12, 12	8.841 (4.3542)	9.323 (4.9569)
Parotid Gland, Aggregated, Median, n=12, 12	7.061 (3.4227)	7.450 (3.8203)
Submandibular Gland, Low, Median, n=9, 8	12.789 (11.7785)	0.775 (0.2742)
Submandibular Gland, High, Median, n=9, 8	17.315 (12.2640)	1.606 (0.5826)
Submandibular Gland, Aggregated, Median, n=11,11	12.146 (9.8325)	1.421 (0.6603)

15. Secondary Outcome

Title	Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Description	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.
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

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	8	12
Parotid Gland, Low	0.0574 (0.02282)	0.0425 (0.02200)
Parotid Gland, High	0.0608 (0.02411)	0.0472 (0.02293)
Parotid Gland, Aggregated	0.0593 (0.02332)	0.0448 (0.02211)
Submandibular Gland, Low	0.0598 (0.02051)	0.0383 (0.01756)
Submandibular Gland, High	0.0626 (0.02137)	0.0422 (0.01916)
Submandibular Gland, Aggregated	0.0614 (0.02085)	0.0407 (0.01863)

16. Secondary Outcome

Title	Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Description	Blood samples were collected at indicated time points for analysis. Pearson's correlation is presented along with 95% confidence interval.
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

Outcome Measure Data

Analysis Population Description

PK Population

Arm/Group Title	Healthy Participants	Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)	Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
Measure Participants	8	12
Max SUV, Low	-0.066	0.915
Max SUV, High	-0.106	0.884
Max SUV, Aggregated	-0.100	0.891
Mean SUV, Low	0.142	0.895
Mean SUV, High	0.130	0.786
Peak SUV, Low	0.045	0.929
Peak SUV, High	0.053	0.866
Peak SUV, Aggregated	0.038	0.906

Adverse Events

Time Frame	Non-serious adverse events and serious adverse events (SAE) were collected up to 11 weeks
Adverse Event Reporting Description	Non-serious adverse events and SAEs were collected for Safety Population
Arm/Group Title	Healthy Participants		Participants With pSS
Arm/Group Description	Underwent an MRI of the salivary glands with one-time IV bolus injection of 0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injection of 500 MBq of 11C-MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)		Underwent an MRI of the salivary glands with IV bolus injection of <=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
All Cause Mortality
	Healthy Participants		Participants With pSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)
Serious Adverse Events
	Healthy Participants		Participants With pSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Participants		Participants With pSS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/13 (7.7%)		1/12 (8.3%)
Nervous system disorders
Headache	1/13 (7.7%)	1	1/12 (8.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.