Autoimmune Diseases
Conditions
Keywords
PET/CT, Primary Sjögren's Syndrome, Magnetic resonance imaging, 11^C-MET, 18^F-FDG
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.
Interventions
RADIATION18F-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
RADIATION11C-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
PROCEDUREMRI 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.
PROCEDUREMinor Salivary gland (labial) biopsy
A minor salivary gland biopsy will be performed at Visit 2 for pSS subjects only.
Sponsors
Quintiles, Inc.
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United Kingdom
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 details
A total of 25 participants were enrolled in the study. The study was conducted at 3 centers in the United Kingdom.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Participants 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) | 13 |
| Participants With pSS 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). | 12 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Healthy Participants | Participants With pSS |
|---|---|---|---|
| Age, Continuous | 48.5 Years STANDARD_DEVIATION 13.51 | 48.1 Years STANDARD_DEVIATION 13.87 | 49.0 Years STANDARD_DEVIATION 13.7 |
| Race/Ethnicity, Customized Asian: Central/south Asian heritage | 3 Count of Participants | 0 Count of Participants | 3 Count of Participants |
| Race/Ethnicity, Customized Asian: South East Asian heritage | 1 Count of Participants | 0 Count of Participants | 1 Count of Participants |
| Race/Ethnicity, Customized Black British | 1 Count of Participants | 0 Count of Participants | 1 Count of Participants |
| Race/Ethnicity, Customized Black or African American | 2 Count of Participants | 2 Count of Participants | 0 Count of Participants |
| Race/Ethnicity, Customized Mixed race White Caribbean | 1 Count of Participants | 1 Count of Participants | 0 Count of Participants |
| Race/Ethnicity, Customized Unknown | 2 Count of Participants | 0 Count of Participants | 2 Count of Participants |
| Race/Ethnicity, Customized White/Caucasian/European Heritage | 15 Count of Participants | 10 Count of Participants | 5 Count of Participants |
| Sex: Female, Male Female | 25 Participants | 13 Participants | 12 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 12 |
| other Total, other adverse events | 1 / 13 | 1 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Low, IQR, n=12, 11 | 0.511 10^-3 square millimeter per second | Standard Error 0.0314 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, High, Median, n=12, 10 | 1.540 10^-3 square millimeter per second | Standard Error 0.0461 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, High, IQR, n=12, 11 | 0.581 10^-3 square millimeter per second | Standard Error 0.0275 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Aggregated, IQR, n=12, 11 | 0.544 10^-3 square millimeter per second | Standard Error 0.0264 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Low, IQR, n=12, 10 | 0.549 10^-3 square millimeter per second | Standard Error 0.0321 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, High, IQR, n=12, 10 | 0.674 10^-3 square millimeter per second | Standard Error 0.0309 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Aggregated, IQR, n=12, 11 | 0.602 10^-3 square millimeter per second | Standard Error 0.0303 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Low, Median, n=12, 11 | 1.091 10^-3 square millimeter per second | Standard Error 0.0476 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, High, Median, n=12, 11 | 1.153 10^-3 square millimeter per second | Standard Error 0.0451 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Aggregated, Median, n=12, 11 | 1.120 10^-3 square millimeter per second | Standard Error 0.046 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Low, Median, n=12, 10 | 1.469 10^-3 square millimeter per second | Standard Error 0.0377 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Aggregated, Median, n=12, 11 | 1.506 10^-3 square millimeter per second | Standard Error 0.0396 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, High, Median, n=12, 10 | 1.551 10^-3 square millimeter per second | Standard Error 0.0833 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Aggregated, Median, n=12, 11 | 1.069 10^-3 square millimeter per second | Standard Error 0.0539 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Aggregated, IQR, n=12, 11 | 0.809 10^-3 square millimeter per second | Standard Error 0.0695 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Low, IQR, n=12, 11 | 0.516 10^-3 square millimeter per second | Standard Error 0.0356 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Aggregated, Median, n=12, 11 | 1.474 10^-3 square millimeter per second | Standard Error 0.0767 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, High, IQR, n=12, 11 | 0.646 10^-3 square millimeter per second | Standard Error 0.0412 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Low, Median, n=12, 11 | 1.011 10^-3 square millimeter per second | Standard Error 0.0607 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, Aggregated, IQR, n=12, 11 | 0.582 10^-3 square millimeter per second | Standard Error 0.0408 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Low, Median, n=12, 10 | 1.410 10^-3 square millimeter per second | Standard Error 0.0924 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, Low, IQR, n=12, 10 | 0.765 10^-3 square millimeter per second | Standard Error 0.0693 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Parotid Gland, High, Median, n=12, 11 | 1.117 10^-3 square millimeter per second | Standard Error 0.0524 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC) | Submandibular Gland, High, IQR, n=12, 10 | 0.928 10^-3 square millimeter per second | Standard Error 0.0714 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Low, IQR, n=12, 12 | 7.618 Per minute | Standard Error 3.8286 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, High, IQR, n=12, 12 | 12.821 Per minute | Standard Error 6.7497 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Aggregated, IQR, n=12, 12 | 10.701 Per minute | Standard Error 5.5677 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Low, IQR, n=9, 8 | 5.548 Per minute | Standard Error 4.651 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, High, IQR, n=9, 8 | 15.192 Per minute | Standard Error 9.3625 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Aggregated, IQR, n=11, 11 | 10.191 Per minute | Standard Error 6.1313 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Low, Median, n=12, 12 | 5.598 Per minute | Standard Error 2.591 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, High, Median, n=12, 12 | 8.841 Per minute | Standard Error 4.3542 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Aggregated, Median, n=12, 12 | 7.061 Per minute | Standard Error 3.4227 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Low, Median, n=9, 8 | 12.789 Per minute | Standard Error 11.7785 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, High, Median, n=9, 8 | 17.315 Per minute | Standard Error 12.264 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Aggregated, Median, n=11,11 | 12.146 Per minute | Standard Error 9.8325 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, High, Median, n=9, 8 | 1.606 Per minute | Standard Error 0.5826 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Low, IQR, n=12, 12 | 22.492 Per minute | Standard Error 9.8803 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Low, Median, n=12, 12 | 3.326 Per minute | Standard Error 1.3677 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, High, IQR, n=12, 12 | 30.199 Per minute | Standard Error 13.2411 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Low, Median, n=9, 8 | 0.775 Per minute | Standard Error 0.2742 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Aggregated, IQR, n=12, 12 | 27.213 Per minute | Standard Error 12.3396 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, High, Median, n=12, 12 | 9.323 Per minute | Standard Error 4.9569 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Low, IQR, n=9, 8 | 0.459 Per minute | Standard Error 0.085 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Aggregated, Median, n=11,11 | 1.421 Per minute | Standard Error 0.6603 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, High, IQR, n=9, 8 | 19.914 Per minute | Standard Error 17.5121 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Parotid Gland, Aggregated, Median, n=12, 12 | 7.450 Per minute | Standard Error 3.8203 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans) | Submandibular Gland, Aggregated, IQR, n=11, 11 | 1.801 Per minute | Standard Error 0.8246 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Low, IQR, n=12, 11 | 0.135 Ratio | Standard Error 0.0084 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, High, IQR, n=12, 11 | 0.164 Ratio | Standard Error 0.0082 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Aggregated, IQR, n=12, 11 | 0.149 Ratio | Standard Error 0.009 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Low, IQR, n=12, 10 | 0.204 Ratio | Standard Error 0.0126 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, High, IQR, n=12, 10 | 0.233 Ratio | Standard Error 0.0143 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Aggregated, IQR, n=12, 11 | 0.219 Ratio | Standard Error 0.0135 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Low, Median, n=12, 11 | 0.131 Ratio | Standard Error 0.0068 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, High, Median, n=12, 11 | 0.151 Ratio | Standard Error 0.0098 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Aggregated, Median, n=12, 11 | 0.140 Ratio | Standard Error 0.0079 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Low, Median, n=12, 10 | 0.198 Ratio | Standard Error 0.0164 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, High, Median, n=12, 10 | 0.223 Ratio | Standard Error 0.0167 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Aggregated, Median, n=12, 11 | 0.210 Ratio | Standard Error 0.0165 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, High, Median, n=12, 10 | 0.271 Ratio | Standard Error 0.0257 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Low, IQR, n=12, 11 | 0.135 Ratio | Standard Error 0.0122 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Low, Median, n=12, 11 | 0.139 Ratio | Standard Error 0.0068 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, High, IQR, n=12, 11 | 0.172 Ratio | Standard Error 0.0155 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Low, Median, n=12, 10 | 0.238 Ratio | Standard Error 0.0263 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Aggregated, IQR, n=12, 11 | 0.156 Ratio | Standard Error 0.0145 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, High, Median, n=12, 11 | 0.164 Ratio | Standard Error 0.0127 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Low, IQR, n=12, 10 | 0.205 Ratio | Standard Error 0.0101 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Aggregated, Median, n=12, 11 | 0.243 Ratio | Standard Error 0.0273 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, High, IQR, n=12, 10 | 0.233 Ratio | Standard Error 0.0102 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Parotid Gland, Aggregated, Median, n=12, 11 | 0.151 Ratio | Standard Error 0.01 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction | Submandibular Gland, Aggregated, IQR, n=12, 11 | 0.217 Ratio | Standard Error 0.0097 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, High, IQR, n=12, 11 | 0.503 10^-3 square millimeter per second | Standard Error 0.0336 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Low, Median, n=12, 11 | 0.771 10^-3 square millimeter per second | Standard Error 0.0269 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Low, IQR, n=12, 10 | 0.553 10^-3 square millimeter per second | Standard Error 0.0361 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, High, Median, n=12, 11 | 0.807 10^-3 square millimeter per second | Standard Error 0.0287 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Low, IQR, n=12, 11 | 0.437 10^-3 square millimeter per second | Standard Error 0.0343 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Aggregated, Median, n=12, 11 | 0.787 10^-3 square millimeter per second | Standard Error 0.0274 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, High, IQR, n=12, 10 | 0.733 10^-3 square millimeter per second | Standard Error 0.0377 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Low, Median, n=12, 10 | 0.941 10^-3 square millimeter per second | Standard Error 0.0445 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Aggregated, IQR, n=12, 11 | 0.468 10^-3 square millimeter per second | Standard Error 0.0344 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, High, Median, n=12, 10 | 1.035 10^-3 square millimeter per second | Standard Error 0.0402 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Aggregated, Median, n=12, 11 | 0.993 10^-3 square millimeter per second | Standard Error 0.0409 |
| Participants With pSS | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Aggregated, IQR, n=12, 11 | 0.636 10^-3 square millimeter per second | Standard Error 0.0324 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Aggregated, Median, n=12, 11 | 0.807 10^-3 square millimeter per second | Standard Error 0.0905 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Low, IQR, n=12, 11 | 0.449 10^-3 square millimeter per second | Standard Error 0.0326 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, High, IQR, n=12, 11 | 0.529 10^-3 square millimeter per second | Standard Error 0.0296 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Aggregated, IQR, n=12, 11 | 0.493 10^-3 square millimeter per second | Standard Error 0.0322 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Low, IQR, n=12, 10 | 0.547 10^-3 square millimeter per second | Standard Error 0.044 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, High, IQR, n=12, 10 | 0.681 10^-3 square millimeter per second | Standard Error 0.0641 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Aggregated, IQR, n=12, 11 | 0.608 10^-3 square millimeter per second | Standard Error 0.0443 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Low, Median, n=12, 11 | 0.621 10^-3 square millimeter per second | Standard Error 0.0492 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, High, Median, n=12, 11 | 0.715 10^-3 square millimeter per second | Standard Error 0.045 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Parotid Gland, Aggregated, Median, n=12, 11 | 0.676 10^-3 square millimeter per second | Standard Error 0.0457 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, Low, Median, n=12, 10 | 0.733 10^-3 square millimeter per second | Standard Error 0.0924 |
| Healthy Participants | Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D) | Submandibular Gland, High, Median, n=12, 10 | 0.814 10^-3 square millimeter per second | Standard Error 0.0887 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Lumbar Vertebra, Max SUV | 4.0225 Grams per milliliter | Standard Deviation 0.91105 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Pancreas, Max SUV | 4.2700 Grams per milliliter | Standard Deviation 1.02711 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Liver, Mean SUV | 2.273 Grams per milliliter | Standard Deviation 0.2605 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Lumbar Vertebra, Mean SUV | 2.105 Grams per milliliter | Standard Deviation 0.4 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Pancreas, Mean SUV | 1.874 Grams per milliliter | Standard Deviation 0.2511 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Spleen, Mean SUV | 1.751 Grams per milliliter | Standard Deviation 0.1889 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Thyroid, Mean SUV | 1.822 Grams per milliliter | Standard Deviation 0.5509 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Aorta, Peak SUV | 2.0125 Grams per milliliter | Standard Deviation 0.35028 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Aorta, Max SUV | 2.9067 Grams per milliliter | Standard Deviation 0.49445 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Liver, Max SUV | 5.0683 Grams per milliliter | Standard Deviation 1.13564 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Muscle, Max SUV | 1.4558 Grams per milliliter | Standard Deviation 0.50282 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Salivary gland, Max SUV | 3.1067 Grams per milliliter | Standard Deviation 0.83496 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Spleen, Max SUV | 3.2333 Grams per milliliter | Standard Deviation 0.54135 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Thyroid, Max SUV | 3.1408 Grams per milliliter | Standard Deviation 0.72742 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Aorta, Mean SUV | 1.883 Grams per milliliter | Standard Deviation 0.274 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Muscle, Mean SUV | 0.657 Grams per milliliter | Standard Deviation 0.1696 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Liver, Peak SUV | 3.2700 Grams per milliliter | Standard Deviation 0.53533 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Lumbar Vertebra, Peak SUV | 2.8242 Grams per milliliter | Standard Deviation 0.58906 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Muscle, Peak SUV | 0.8833 Grams per milliliter | Standard Deviation 0.25378 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Pancreas, Peak SUV | 2.6892 Grams per milliliter | Standard Deviation 0.47389 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Salivary gland, Peak SUV | 2.1425 Grams per milliliter | Standard Deviation 0.58856 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Spleen, Peak SUV | 2.3475 Grams per milliliter | Standard Deviation 0.30266 |
| Participants With pSS | Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas | Thyroid, Peak SUV | 2.2458 Grams per milliliter | Standard Deviation 0.68193 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Spleen, Peak SUV | 3.6975 Grams per milliliter | Standard Deviation 0.61556 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Thyroid, Peak SUV | 2.6000 Grams per milliliter | Standard Deviation 0.65448 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Thyroid, Mean SUV | 2.149 Grams per milliliter | Standard Deviation 0.6418 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Aorta, Max SUV | 2.2700 Grams per milliliter | Standard Deviation 0.72709 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Muscle, Mean SUV | 0.968 Grams per milliliter | Standard Deviation 0.2074 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Liver, Max SUV | 19.1667 Grams per milliliter | Standard Deviation 3.81783 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Aorta, Peak SUV | 1.3250 Grams per milliliter | Standard Deviation 0.3759 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Lumbar Vertebra, Max SUV | 7.1733 Grams per milliliter | Standard Deviation 2.85382 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Salivary gland, Peak SUV | 3.3633 Grams per milliliter | Standard Deviation 1.16624 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Muscle, Max SUV | 2.4167 Grams per milliliter | Standard Deviation 0.89879 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Lumbar Vertebra, Peak SUV | 4.7317 Grams per milliliter | Standard Deviation 1.28105 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Pancreas, Max SUV | 31.4492 Grams per milliliter | Standard Deviation 5.17911 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Pancreas, Mean SUV | 16.413 Grams per milliliter | Standard Deviation 3.1008 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Salivary gland, Max SUV | 5.4275 Grams per milliliter | Standard Deviation 1.43053 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Muscle, Peak SUV | 1.3675 Grams per milliliter | Standard Deviation 0.40656 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Spleen, Max SUV | 5.5100 Grams per milliliter | Standard Deviation 1.357 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Liver, Peak SUV | 14.7808 Grams per milliliter | Standard Deviation 3.01666 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Thyroid, Max SUV | 3.7058 Grams per milliliter | Standard Deviation 0.8645 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Pancreas, Peak SUV | 26.4683 Grams per milliliter | Standard Deviation 4.29608 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Aorta, Mean SUV | 1.161 Grams per milliliter | Standard Deviation 0.2927 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Spleen, Mean SUV | 2.650 Grams per milliliter | Standard Deviation 0.3745 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Liver, Mean SUV | 10.926 Grams per milliliter | Standard Deviation 2.1692 |
| Participants With pSS | SUV for 11C- MET in Selected Body Areas | Lumbar Vertebra, Mean SUV | 3.485 Grams per milliliter | Standard Deviation 0.9351 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Liver, Mean SUV | 8.916 Grams per milliliter | Standard Deviation 1.438 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Lumbar Vertebra, Mean SUV | 2.923 Grams per milliliter | Standard Deviation 0.5387 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Aorta, Peak SUV | 1.1338 Grams per milliliter | Standard Deviation 0.41008 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Salivary gland, Peak SUV | 5.0600 Grams per milliliter | Standard Deviation 0.83111 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Muscle, Mean SUV | 0.926 Grams per milliliter | Standard Deviation 0.2365 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Pancreas, Mean SUV | 16.556 Grams per milliliter | Standard Deviation 2.9023 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Spleen, Mean SUV | 2.423 Grams per milliliter | Standard Deviation 0.1005 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Thyroid, Mean SUV | 1.646 Grams per milliliter | Standard Deviation 0.3138 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Liver, Peak SUV | 12.3438 Grams per milliliter | Standard Deviation 1.76812 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Lumbar Vertebra, Peak SUV | 3.8775 Grams per milliliter | Standard Deviation 0.62923 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Muscle, Peak SUV | 1.3100 Grams per milliliter | Standard Deviation 0.29544 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Pancreas, Peak SUV | 26.7913 Grams per milliliter | Standard Deviation 6.217 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Spleen, Peak SUV | 3.4100 Grams per milliliter | Standard Deviation 0.35633 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Thyroid, Peak SUV | 2.0525 Grams per milliliter | Standard Deviation 0.29673 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Aorta, Max SUV | 2.0275 Grams per milliliter | Standard Deviation 0.62609 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Liver, Max SUV | 16.4213 Grams per milliliter | Standard Deviation 3.31237 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Lumbar Vertebra, Max SUV | 5.9100 Grams per milliliter | Standard Deviation 1.43376 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Muscle, Max SUV | 2.3513 Grams per milliliter | Standard Deviation 1.01454 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Pancreas, Max SUV | 31.7388 Grams per milliliter | Standard Deviation 5.68871 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Salivary gland, Max SUV | 6.6900 Grams per milliliter | Standard Deviation 1.05224 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Spleen, Max SUV | 5.2750 Grams per milliliter | Standard Deviation 1.22413 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Thyroid, Max SUV | 3.1038 Grams per milliliter | Standard Deviation 0.79784 |
| Healthy Participants | SUV for 11C- MET in Selected Body Areas | Aorta, Mean SUV | 1.029 Grams per milliliter | Standard Deviation 0.3334 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, High, Max SUV | 4.9492 Grams per milliliter | Standard Deviation 1.22415 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, High, Mean SUV | 2.925 Grams per milliliter | Standard Deviation 0.8679 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Aggregated, Max SUV | 4.9492 Grams per milliliter | Standard Deviation 1.22415 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Low, Mean SUV | 2.388 Grams per milliliter | Standard Deviation 1.1855 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, High, Max SUV | 2.1483 Grams per milliliter | Standard Deviation 1.02205 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, High, Mean SUV | 2.648 Grams per milliliter | Standard Deviation 1.2128 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Low, Max SUV | 3.8583 Grams per milliliter | Standard Deviation 1.78484 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Low, Peak SUV | 1.3525 Grams per milliliter | Standard Deviation 0.59715 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Low, Peak SUV | 3.4367 Grams per milliliter | Standard Deviation 1.22748 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, High, Peak SUV | 1.4958 Grams per milliliter | Standard Deviation 0.65626 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, High, Max SUV | 4.4692 Grams per milliliter | Standard Deviation 1.77872 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Aggregated, Peak SUV | 1.4233 Grams per milliliter | Standard Deviation 0.62222 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Aggregated, Max SUV | 2.1483 Grams per milliliter | Standard Deviation 1.02205 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Aggregated, Max SUV | 4.4692 Grams per milliliter | Standard Deviation 1.77872 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, High, Peak SUV | 3.9175 Grams per milliliter | Standard Deviation 1.18255 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Low, Mean SUV | 1.312 Grams per milliliter | Standard Deviation 0.6048 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Aggregated, Peak SUV | 3.6767 Grams per milliliter | Standard Deviation 1.18792 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, High, Mean SUV | 1.462 Grams per milliliter | Standard Deviation 0.649 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Low, Peak SUV | 2.8025 Grams per milliliter | Standard Deviation 1.53196 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Low, Max SUV | 4.3933 Grams per milliliter | Standard Deviation 1.31072 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, High, Peak SUV | 3.2992 Grams per milliliter | Standard Deviation 1.63167 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Low, Mean SUV | 2.525 Grams per milliliter | Standard Deviation 0.874 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Aggregated, Peak SUV | 3.0517 Grams per milliliter | Standard Deviation 1.56359 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Low, Max SUV | 1.9133 Grams per milliliter | Standard Deviation 1.00469 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Aggregated, Peak SUV | 5.0838 Grams per milliliter | Standard Deviation 0.8649 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Low, Max SUV | 5.9038 Grams per milliliter | Standard Deviation 1.01547 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, High, Max SUV | 6.3750 Grams per milliliter | Standard Deviation 1.09929 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Aggregated, Max SUV | 6.5488 Grams per milliliter | Standard Deviation 0.94266 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Low, Max SUV | 2.5513 Grams per milliliter | Standard Deviation 1.00049 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, High, Max SUV | 3.1250 Grams per milliliter | Standard Deviation 1.49196 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Aggregated, Max SUV | 3.1250 Grams per milliliter | Standard Deviation 1.49196 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Aggregated, Max SUV | 6.3750 Grams per milliliter | Standard Deviation 1.09929 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Low, Max SUV | 6.2150 Grams per milliliter | Standard Deviation 1.06158 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, High, Max SUV | 6.5488 Grams per milliliter | Standard Deviation 0.94266 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Low, Mean SUV | 1.703 Grams per milliliter | Standard Deviation 0.581 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, High, Mean SUV | 2.056 Grams per milliliter | Standard Deviation 0.7874 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Low, Mean SUV | 3.505 Grams per milliliter | Standard Deviation 0.5637 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, High, Mean SUV | 3.648 Grams per milliliter | Standard Deviation 0.5709 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Low, Mean SUV | 3.923 Grams per milliliter | Standard Deviation 0.4941 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, High, Mean SUV | 4.191 Grams per milliliter | Standard Deviation 0.541 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Low, Peak SUV | 1.7738 Grams per milliliter | Standard Deviation 0.66125 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, High, Peak SUV | 2.1688 Grams per milliliter | Standard Deviation 0.9958 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Lachrymal gland, Aggregated, Peak SUV | 1.9713 Grams per milliliter | Standard Deviation 0.81354 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Low, Peak SUV | 4.9000 Grams per milliliter | Standard Deviation 0.92893 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, High, Peak SUV | 5.1663 Grams per milliliter | Standard Deviation 0.85276 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Parotid gland, Aggregated, Peak SUV | 5.0325 Grams per milliliter | Standard Deviation 0.8902 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, Low, Peak SUV | 4.8588 Grams per milliliter | Standard Deviation 0.86087 |
| Healthy Participants | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET | Submandibular gland, High, Peak SUV | 5.3100 Grams per milliliter | Standard Deviation 0.89113 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Aggregated, Max SUV | 2.0658 Grams per milliliter | Standard Deviation 0.34849 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Low, Max SUV | 2.5767 Grams per milliliter | Standard Deviation 0.68672 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, High, Max SUV | 2.9250 Grams per milliliter | Standard Deviation 0.94362 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Low, Mean SUV | 1.620 Grams per milliliter | Standard Deviation 0.5022 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Low, Peak SUV | 1.5842 Grams per milliliter | Standard Deviation 0.18535 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Low, Max SUV | 1.7808 Grams per milliliter | Standard Deviation 0.38311 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, High, Max SUV | 2.0658 Grams per milliliter | Standard Deviation 0.34849 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, High, Max SUV | 2.7783 Grams per milliliter | Standard Deviation 0.76902 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Aggregated, Max SUV | 2.7783 Grams per milliliter | Standard Deviation 0.76902 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Low, Max SUV | 2.5200 Grams per milliliter | Standard Deviation 0.82131 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Aggregated, Max SUV | 2.9250 Grams per milliliter | Standard Deviation 0.94362 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Low, Mean SUV | 1.311 Grams per milliliter | Standard Deviation 0.3218 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, High, Mean SUV | 1.515 Grams per milliliter | Standard Deviation 0.2934 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, High, Mean SUV | 1.818 Grams per milliliter | Standard Deviation 0.5957 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Low, Mean SUV | 1.709 Grams per milliliter | Standard Deviation 0.6786 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, High, Mean SUV | 1.916 Grams per milliliter | Standard Deviation 0.6237 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, High, Peak SUV | 1.7125 Grams per milliliter | Standard Deviation 0.24264 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Aggregated, Peak SUV | 1.6492 Grams per milliliter | Standard Deviation 0.20505 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Low, Peak SUV | 2.0150 Grams per milliliter | Standard Deviation 0.6459 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, High, Peak SUV | 2.2383 Grams per milliliter | Standard Deviation 0.71837 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Aggregated, Peak SUV | 2.1275 Grams per milliliter | Standard Deviation 0.67216 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Low, Peak SUV | 1.9275 Grams per milliliter | Standard Deviation 0.7462 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, High, Peak SUV | 2.3883 Grams per milliliter | Standard Deviation 0.69049 |
| Participants With pSS | SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Aggregated, Peak SUV | 2.1583 Grams per milliliter | Standard Deviation 0.67168 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Aorta | 1.0660 Ratio | Standard Deviation 0.05729 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Liver | 1.7366 Ratio | Standard Deviation 0.11645 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Lumbar Vertebra | 1.5096 Ratio | Standard Deviation 0.28568 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Muscle | 0.4669 Ratio | Standard Deviation 0.10222 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Pancreas | 1.4312 Ratio | Standard Deviation 0.1649 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Salivary gland | 1.1730 Ratio | Standard Deviation 0.38592 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Spleen | 1.2625 Ratio | Standard Deviation 0.174 |
| Participants With pSS | Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants | Thyroid | 1.2193 Ratio | Standard Deviation 0.44934 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Data was not collected
Primary
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
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Data was not collected
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | TR Ratio for 11C- MET | Thyroid | 2.3002 Ratio | Standard Deviation 0.63142 |
| Participants With pSS | TR Ratio for 11C- MET | Muscle | 1.1914 Ratio | Standard Deviation 0.26802 |
| Participants With pSS | TR Ratio for 11C- MET | Liver | 13.1513 Ratio | Standard Deviation 3.13572 |
| Participants With pSS | TR Ratio for 11C- MET | Pancreas | 23.5403 Ratio | Standard Deviation 4.6214 |
| Participants With pSS | TR Ratio for 11C- MET | Aorta | 1.1352 Ratio | Standard Deviation 0.06738 |
| Participants With pSS | TR Ratio for 11C- MET | Salivary gland | 3.0974 Ratio | Standard Deviation 1.30105 |
| Participants With pSS | TR Ratio for 11C- MET | Lumbar Vertebra | 4.1158 Ratio | Standard Deviation 0.85314 |
| Participants With pSS | TR Ratio for 11C- MET | Spleen | 3.2872 Ratio | Standard Deviation 0.6747 |
| Healthy Participants | TR Ratio for 11C- MET | Lumbar Vertebra | 3.9731 Ratio | Standard Deviation 0.80867 |
| Healthy Participants | TR Ratio for 11C- MET | Thyroid | 2.1213 Ratio | Standard Deviation 0.4967 |
| Healthy Participants | TR Ratio for 11C- MET | Aorta | 1.0910 Ratio | Standard Deviation 0.04942 |
| Healthy Participants | TR Ratio for 11C- MET | Liver | 12.8649 Ratio | Standard Deviation 3.46136 |
| Healthy Participants | TR Ratio for 11C- MET | Spleen | 3.5414 Ratio | Standard Deviation 0.81253 |
| Healthy Participants | TR Ratio for 11C- MET | Muscle | 1.3354 Ratio | Standard Deviation 0.34831 |
| Healthy Participants | TR Ratio for 11C- MET | Pancreas | 29.8331 Ratio | Standard Deviation 15.21426 |
| Healthy Participants | TR Ratio for 11C- MET | Salivary gland | 5.2805 Ratio | Standard Deviation 1.44642 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Lachrymal gland, High | 1.3178 Ratio | Standard Deviation 0.59115 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Parotid gland, Aggregated | 3.4003 Ratio | Standard Deviation 1.41542 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Parotid gland, Low | 3.1810 Ratio | Standard Deviation 1.44525 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Submandibular gland, Low | 2.5766 Ratio | Standard Deviation 1.61682 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Lachrymal gland, Aggregated | 1.2594 Ratio | Standard Deviation 0.57188 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Submandibular gland, High | 3.0126 Ratio | Standard Deviation 1.61982 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Parotid gland, High | 3.6198 Ratio | Standard Deviation 1.41338 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Submandibular gland, Aggregated | 2.7946 Ratio | Standard Deviation 1.60578 |
| Participants With pSS | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Lachrymal gland, Low | 1.2007 Ratio | Standard Deviation 0.55639 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Submandibular gland, Aggregated | 5.2513 Ratio | Standard Deviation 1.24653 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Lachrymal gland, Low | 1.8219 Ratio | Standard Deviation 0.62711 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Lachrymal gland, High | 2.1965 Ratio | Standard Deviation 0.76588 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Lachrymal gland, Aggregated | 2.0094 Ratio | Standard Deviation 0.68084 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Parotid gland, Low | 5.1570 Ratio | Standard Deviation 1.61371 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Parotid gland, High | 5.4621 Ratio | Standard Deviation 1.73285 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Parotid gland, Aggregated | 5.3096 Ratio | Standard Deviation 1.67006 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Submandibular gland, Low | 5.0230 Ratio | Standard Deviation 1.20994 |
| Healthy Participants | TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland | Submandibular gland, High | 5.4796 Ratio | Standard Deviation 1.30126 |
Primary
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.
Time frame: Visit 1: Within 6 weeks after Baseline
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Low | 0.8529 Ratio | Standard Deviation 0.1225 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, High | 0.9201 Ratio | Standard Deviation 0.13587 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Lachrymal gland, Aggregated | 0.8864 Ratio | Standard Deviation 0.1256 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Low | 1.1158 Ratio | Standard Deviation 0.44262 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, High | 1.2338 Ratio | Standard Deviation 0.47055 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Parotid gland, Aggregated | 1.1749 Ratio | Standard Deviation 0.45273 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Low | 1.0472 Ratio | Standard Deviation 0.43105 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, High | 1.2953 Ratio | Standard Deviation 0.41063 |
| Participants With pSS | TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants | Submandibular gland, Aggregated | 1.1711 Ratio | Standard Deviation 0.40012 |
Secondary
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.
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
Population: PK Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Max SUV, Low | -0.066 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Mean SUV, High | 0.130 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Max SUV, Aggregated | -0.100 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Peak SUV, Low | 0.045 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Peak SUV, High | 0.053 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Max SUV, High | -0.106 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Peak SUV, Aggregated | 0.038 Grams per milliliter |
| Participants With pSS | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Mean SUV, Low | 0.142 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Peak SUV, Aggregated | 0.906 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Max SUV, Low | 0.915 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Max SUV, High | 0.884 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Max SUV, Aggregated | 0.891 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Mean SUV, Low | 0.895 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Mean SUV, High | 0.786 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Peak SUV, High | 0.866 Grams per milliliter |
| Healthy Participants | Correlation Between Static and Dynamic Imaging Metrics in 11C-MET | Peak SUV, Low | 0.929 Grams per milliliter |
Secondary
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.
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
Population: PK Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With pSS | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Parotid Gland, Aggregated | 0.0593 Milliliter/centimeter cube/minute | Standard Deviation 0.02332 |
| Participants With pSS | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Submandibular Gland, High | 0.0626 Milliliter/centimeter cube/minute | Standard Deviation 0.02137 |
| Participants With pSS | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Parotid Gland, High | 0.0608 Milliliter/centimeter cube/minute | Standard Deviation 0.02411 |
| Participants With pSS | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Submandibular Gland, Aggregated | 0.0614 Milliliter/centimeter cube/minute | Standard Deviation 0.02085 |
| Participants With pSS | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Submandibular Gland, Low | 0.0598 Milliliter/centimeter cube/minute | Standard Deviation 0.02051 |
| Participants With pSS | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Parotid Gland, Low | 0.0574 Milliliter/centimeter cube/minute | Standard Deviation 0.02282 |
| Healthy Participants | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Submandibular Gland, Low | 0.0383 Milliliter/centimeter cube/minute | Standard Deviation 0.01756 |
| Healthy Participants | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Parotid Gland, High | 0.0472 Milliliter/centimeter cube/minute | Standard Deviation 0.02293 |
| Healthy Participants | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Parotid Gland, Aggregated | 0.0448 Milliliter/centimeter cube/minute | Standard Deviation 0.02211 |
| Healthy Participants | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Parotid Gland, Low | 0.0425 Milliliter/centimeter cube/minute | Standard Deviation 0.022 |
| Healthy Participants | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Submandibular Gland, High | 0.0422 Milliliter/centimeter cube/minute | Standard Deviation 0.01916 |
| Healthy Participants | Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT | Submandibular Gland, Aggregated | 0.0407 Milliliter/centimeter cube/minute | Standard Deviation 0.01863 |