| 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. | | Posted | | Mean | Standard Deviation | Grams per milliliter | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). |
| | | Title | Denominators | Categories |
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| Aorta, Max SUV | | | | Liver, Max SUV | | | | Lumbar Vertebra, Max SUV | | |
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| 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. | | Posted | | Mean | Standard Deviation | Grams per milliliter | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | | Posted | | Mean | Standard Deviation | Ratio | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | | Posted | | Mean | Standard Deviation | Ratio | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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 | Safety Population. Data was not collected | Posted | | | | | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Grams per milliliter | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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) |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Grams per milliliter | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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). | | OG001 | 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) |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Ratio | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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) |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed | Posted | | Mean | Standard Deviation | Ratio | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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) |
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| 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. | Safety Population. Data was not collected | Posted | | | | | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
|---|
| OG000 | 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). | | OG001 | 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) |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | 10^-3 square millimeter per second | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | 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). |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | 10^-3 square millimeter per second | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | 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). |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | Ratio | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | 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). |
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| 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. | Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). | Posted | | Mean | Standard Error | Per minute | | Visit 1: Within 6 weeks after Baseline | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | 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). |
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| 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. | | Posted | | Mean | Standard Deviation | Milliliter/centimeter cube/minute | | 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 | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | 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). |
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| 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. | | Posted | | Number | 95% Confidence Interval | Grams per milliliter | | 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 | | | | ID | Title | Description |
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| OG000 | 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) | | OG001 | 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). |
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