Trial Outcomes & Findings for A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS Pts (NCT NCT02899377)
NCT ID: NCT02899377
Last Updated: 2019-10-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Visit 1: Within 6 weeks after Baseline
Results posted on
2019-10-25
Participant Flow
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.
A total of 25 participants were enrolled in the study. The study was conducted at 3 centers in the United Kingdom.
Participant milestones
| Measure |
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-flurodeoxyglucose (FDG) followed by a PET/CT (static head to hip scan).
|
Healthy Participants
Underwent an MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 millimoles (mmol)/kilogram (kg) of gadoterate meglumine and received one-time IV bolus injection of 500 megabecquerels (MBq) of carbon11-methionine (11C -MET) followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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-flurodeoxyglucose (FDG) followed by a PET/CT (static head to hip scan).
|
Healthy Participants
Underwent an MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 millimoles (mmol)/kilogram (kg) of gadoterate meglumine and received one-time IV bolus injection of 500 megabecquerels (MBq) of carbon11-methionine (11C -MET) followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS Pts
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=13 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)
|
Participants With pSS
n=12 Participants
Underwent an MRI of the salivary glands with IV bolus injection of \<=0.1 mmol/kg of gadoterate meglumine and received one-time IV bolus injections: 500 MBq of 11C-MET and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan).
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.1 Years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
49.0 Years
STANDARD_DEVIATION 13.70 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 13.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: Central/south Asian heritage
|
0 Count of Participants
n=5 Participants
|
3 Count of Participants
n=7 Participants
|
3 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian: South East Asian heritage
|
0 Count of Participants
n=5 Participants
|
1 Count of Participants
n=7 Participants
|
1 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian/European Heritage
|
10 Count of Participants
n=5 Participants
|
5 Count of Participants
n=7 Participants
|
15 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed race White Caribbean
|
1 Count of Participants
n=5 Participants
|
0 Count of Participants
n=7 Participants
|
1 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Count of Participants
n=5 Participants
|
2 Count of Participants
n=7 Participants
|
2 Count of Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black British
|
0 Count of Participants
n=5 Participants
|
1 Count of Participants
n=7 Participants
|
1 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
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)
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas
Aorta, Mean SUV
|
1.883 Grams per milliliter
Standard Deviation 0.2740
|
—
|
|
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
|
—
|
|
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 0.4000
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
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)
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 0.64590
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 0.74620
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
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)
|
|---|---|---|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Aorta
|
1.0660 Ratio
Standard Deviation 0.05729
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Liver
|
1.7366 Ratio
Standard Deviation 0.11645
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Lumbar Vertebra
|
1.5096 Ratio
Standard Deviation 0.28568
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Muscle
|
0.4669 Ratio
Standard Deviation 0.10222
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Pancreas
|
1.4312 Ratio
Standard Deviation 0.16490
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Salivary gland
|
1.1730 Ratio
Standard Deviation 0.38592
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Spleen
|
1.2625 Ratio
Standard Deviation 0.17400
|
—
|
|
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
Thyroid
|
1.2193 Ratio
Standard Deviation 0.44934
|
—
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
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)
|
|---|---|---|
|
TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Lachrymal gland, Low
|
0.8529 Ratio
Standard Deviation 0.12250
|
—
|
|
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
|
—
|
|
TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Lachrymal gland, Aggregated
|
0.8864 Ratio
Standard Deviation 0.12560
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Data was not collected
There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
Healthy Participants
n=8 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)
|
|---|---|---|
|
SUV for 11C- MET in Selected Body Areas
Aorta, Max SUV
|
2.2700 Grams per milliliter
Standard Deviation 0.72709
|
2.0275 Grams per milliliter
Standard Deviation 0.62609
|
|
SUV for 11C- MET in Selected Body Areas
Liver, Max SUV
|
19.1667 Grams per milliliter
Standard Deviation 3.81783
|
16.4213 Grams per milliliter
Standard Deviation 3.31237
|
|
SUV for 11C- MET in Selected Body Areas
Lumbar Vertebra, Max SUV
|
7.1733 Grams per milliliter
Standard Deviation 2.85382
|
5.9100 Grams per milliliter
Standard Deviation 1.43376
|
|
SUV for 11C- MET in Selected Body Areas
Muscle, Max SUV
|
2.4167 Grams per milliliter
Standard Deviation 0.89879
|
2.3513 Grams per milliliter
Standard Deviation 1.01454
|
|
SUV for 11C- MET in Selected Body Areas
Pancreas, Max SUV
|
31.4492 Grams per milliliter
Standard Deviation 5.17911
|
31.7388 Grams per milliliter
Standard Deviation 5.68871
|
|
SUV for 11C- MET in Selected Body Areas
Salivary gland, Max SUV
|
5.4275 Grams per milliliter
Standard Deviation 1.43053
|
6.6900 Grams per milliliter
Standard Deviation 1.05224
|
|
SUV for 11C- MET in Selected Body Areas
Spleen, Max SUV
|
5.5100 Grams per milliliter
Standard Deviation 1.35700
|
5.2750 Grams per milliliter
Standard Deviation 1.22413
|
|
SUV for 11C- MET in Selected Body Areas
Thyroid, Max SUV
|
3.7058 Grams per milliliter
Standard Deviation 0.86450
|
3.1038 Grams per milliliter
Standard Deviation 0.79784
|
|
SUV for 11C- MET in Selected Body Areas
Aorta, Mean SUV
|
1.161 Grams per milliliter
Standard Deviation 0.2927
|
1.029 Grams per milliliter
Standard Deviation 0.3334
|
|
SUV for 11C- MET in Selected Body Areas
Liver, Mean SUV
|
10.926 Grams per milliliter
Standard Deviation 2.1692
|
8.916 Grams per milliliter
Standard Deviation 1.4380
|
|
SUV for 11C- MET in Selected Body Areas
Lumbar Vertebra, Mean SUV
|
3.485 Grams per milliliter
Standard Deviation 0.9351
|
2.923 Grams per milliliter
Standard Deviation 0.5387
|
|
SUV for 11C- MET in Selected Body Areas
Muscle, Mean SUV
|
0.968 Grams per milliliter
Standard Deviation 0.2074
|
0.926 Grams per milliliter
Standard Deviation 0.2365
|
|
SUV for 11C- MET in Selected Body Areas
Pancreas, Mean SUV
|
16.413 Grams per milliliter
Standard Deviation 3.1008
|
16.556 Grams per milliliter
Standard Deviation 2.9023
|
|
SUV for 11C- MET in Selected Body Areas
Spleen, Mean SUV
|
2.650 Grams per milliliter
Standard Deviation 0.3745
|
2.423 Grams per milliliter
Standard Deviation 0.1005
|
|
SUV for 11C- MET in Selected Body Areas
Thyroid, Mean SUV
|
2.149 Grams per milliliter
Standard Deviation 0.6418
|
1.646 Grams per milliliter
Standard Deviation 0.3138
|
|
SUV for 11C- MET in Selected Body Areas
Aorta, Peak SUV
|
1.3250 Grams per milliliter
Standard Deviation 0.37590
|
1.1338 Grams per milliliter
Standard Deviation 0.41008
|
|
SUV for 11C- MET in Selected Body Areas
Liver, Peak SUV
|
14.7808 Grams per milliliter
Standard Deviation 3.01666
|
12.3438 Grams per milliliter
Standard Deviation 1.76812
|
|
SUV for 11C- MET in Selected Body Areas
Lumbar Vertebra, Peak SUV
|
4.7317 Grams per milliliter
Standard Deviation 1.28105
|
3.8775 Grams per milliliter
Standard Deviation 0.62923
|
|
SUV for 11C- MET in Selected Body Areas
Muscle, Peak SUV
|
1.3675 Grams per milliliter
Standard Deviation 0.40656
|
1.3100 Grams per milliliter
Standard Deviation 0.29544
|
|
SUV for 11C- MET in Selected Body Areas
Pancreas, Peak SUV
|
26.4683 Grams per milliliter
Standard Deviation 4.29608
|
26.7913 Grams per milliliter
Standard Deviation 6.21700
|
|
SUV for 11C- MET in Selected Body Areas
Salivary gland, Peak SUV
|
3.3633 Grams per milliliter
Standard Deviation 1.16624
|
5.0600 Grams per milliliter
Standard Deviation 0.83111
|
|
SUV for 11C- MET in Selected Body Areas
Spleen, Peak SUV
|
3.6975 Grams per milliliter
Standard Deviation 0.61556
|
3.4100 Grams per milliliter
Standard Deviation 0.35633
|
|
SUV for 11C- MET in Selected Body Areas
Thyroid, Peak SUV
|
2.6000 Grams per milliliter
Standard Deviation 0.65448
|
2.0525 Grams per milliliter
Standard Deviation 0.29673
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
Healthy Participants
n=8 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)
|
|---|---|---|
|
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
|
2.5513 Grams per milliliter
Standard Deviation 1.00049
|
|
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
|
3.1250 Grams per milliliter
Standard Deviation 1.49196
|
|
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
|
3.1250 Grams per milliliter
Standard Deviation 1.49196
|
|
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
|
5.9038 Grams per milliliter
Standard Deviation 1.01547
|
|
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
|
6.3750 Grams per milliliter
Standard Deviation 1.09929
|
|
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
|
6.3750 Grams per milliliter
Standard Deviation 1.09929
|
|
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
|
6.2150 Grams per milliliter
Standard Deviation 1.06158
|
|
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
|
6.5488 Grams per milliliter
Standard Deviation 0.94266
|
|
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
|
6.5488 Grams per milliliter
Standard Deviation 0.94266
|
|
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
|
1.703 Grams per milliliter
Standard Deviation 0.5810
|
|
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
Lachrymal gland, High, Mean SUV
|
1.462 Grams per milliliter
Standard Deviation 0.6490
|
2.056 Grams per milliliter
Standard Deviation 0.7874
|
|
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
Parotid gland, Low, Mean SUV
|
2.525 Grams per milliliter
Standard Deviation 0.8740
|
3.505 Grams per milliliter
Standard Deviation 0.5637
|
|
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
|
3.648 Grams per milliliter
Standard Deviation 0.5709
|
|
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
|
3.923 Grams per milliliter
Standard Deviation 0.4941
|
|
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
|
4.191 Grams per milliliter
Standard Deviation 0.5410
|
|
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
|
1.7738 Grams per milliliter
Standard Deviation 0.66125
|
|
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
|
2.1688 Grams per milliliter
Standard Deviation 0.99580
|
|
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
|
1.9713 Grams per milliliter
Standard Deviation 0.81354
|
|
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
|
4.9000 Grams per milliliter
Standard Deviation 0.92893
|
|
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
|
5.1663 Grams per milliliter
Standard Deviation 0.85276
|
|
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
|
5.0325 Grams per milliliter
Standard Deviation 0.89020
|
|
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
|
4.8588 Grams per milliliter
Standard Deviation 0.86087
|
|
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
|
5.3100 Grams per milliliter
Standard Deviation 0.89113
|
|
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
|
5.0838 Grams per milliliter
Standard Deviation 0.86490
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
Healthy Participants
n=8 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)
|
|---|---|---|
|
TR Ratio for 11C- MET
Aorta
|
1.1352 Ratio
Standard Deviation 0.06738
|
1.0910 Ratio
Standard Deviation 0.04942
|
|
TR Ratio for 11C- MET
Liver
|
13.1513 Ratio
Standard Deviation 3.13572
|
12.8649 Ratio
Standard Deviation 3.46136
|
|
TR Ratio for 11C- MET
Lumbar Vertebra
|
4.1158 Ratio
Standard Deviation 0.85314
|
3.9731 Ratio
Standard Deviation 0.80867
|
|
TR Ratio for 11C- MET
Muscle
|
1.1914 Ratio
Standard Deviation 0.26802
|
1.3354 Ratio
Standard Deviation 0.34831
|
|
TR Ratio for 11C- MET
Pancreas
|
23.5403 Ratio
Standard Deviation 4.62140
|
29.8331 Ratio
Standard Deviation 15.21426
|
|
TR Ratio for 11C- MET
Salivary gland
|
3.0974 Ratio
Standard Deviation 1.30105
|
5.2805 Ratio
Standard Deviation 1.44642
|
|
TR Ratio for 11C- MET
Spleen
|
3.2872 Ratio
Standard Deviation 0.67470
|
3.5414 Ratio
Standard Deviation 0.81253
|
|
TR Ratio for 11C- MET
Thyroid
|
2.3002 Ratio
Standard Deviation 0.63142
|
2.1213 Ratio
Standard Deviation 0.49670
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed
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.
Outcome measures
| Measure |
Participants With pSS
n=12 Participants
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).
|
Healthy Participants
n=8 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)
|
|---|---|---|
|
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
|
1.8219 Ratio
Standard Deviation 0.62711
|
|
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
|
2.1965 Ratio
Standard Deviation 0.76588
|
|
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
|
2.0094 Ratio
Standard Deviation 0.68084
|
|
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
|
5.1570 Ratio
Standard Deviation 1.61371
|
|
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
|
5.4621 Ratio
Standard Deviation 1.73285
|
|
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
|
5.3096 Ratio
Standard Deviation 1.67006
|
|
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
|
5.0230 Ratio
Standard Deviation 1.20994
|
|
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
|
5.4796 Ratio
Standard Deviation 1.30126
|
|
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
|
5.2513 Ratio
Standard Deviation 1.24653
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Data was not collected
There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
Participants With pSS
n=13 Participants
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).
|
Healthy Participants
n=12 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)
|
|---|---|---|
|
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
|
0.516 10^-3 square millimeter per second
Standard Error 0.0356
|
|
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
|
0.646 10^-3 square millimeter per second
Standard Error 0.0412
|
|
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
|
0.582 10^-3 square millimeter per second
Standard Error 0.0408
|
|
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
|
0.765 10^-3 square millimeter per second
Standard Error 0.0693
|
|
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
|
0.928 10^-3 square millimeter per second
Standard Error 0.0714
|
|
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
|
0.809 10^-3 square millimeter per second
Standard Error 0.0695
|
|
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
|
1.011 10^-3 square millimeter per second
Standard Error 0.0607
|
|
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
|
1.117 10^-3 square millimeter per second
Standard Error 0.0524
|
|
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 0.0460
|
1.069 10^-3 square millimeter per second
Standard Error 0.0539
|
|
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
|
1.410 10^-3 square millimeter per second
Standard Error 0.0924
|
|
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
|
1.551 10^-3 square millimeter per second
Standard Error 0.0833
|
|
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
|
1.474 10^-3 square millimeter per second
Standard Error 0.0767
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
Participants With pSS
n=13 Participants
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).
|
Healthy Participants
n=12 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)
|
|---|---|---|
|
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
|
0.449 10^-3 square millimeter per second
Standard Error 0.0326
|
|
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
|
0.529 10^-3 square millimeter per second
Standard Error 0.0296
|
|
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
|
0.493 10^-3 square millimeter per second
Standard Error 0.0322
|
|
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
|
0.547 10^-3 square millimeter per second
Standard Error 0.0440
|
|
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
|
0.681 10^-3 square millimeter per second
Standard Error 0.0641
|
|
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
|
0.608 10^-3 square millimeter per second
Standard Error 0.0443
|
|
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
|
0.621 10^-3 square millimeter per second
Standard Error 0.0492
|
|
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
|
0.715 10^-3 square millimeter per second
Standard Error 0.0450
|
|
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
|
0.676 10^-3 square millimeter per second
Standard Error 0.0457
|
|
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
|
0.733 10^-3 square millimeter per second
Standard Error 0.0924
|
|
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
|
0.814 10^-3 square millimeter per second
Standard Error 0.0887
|
|
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
|
0.807 10^-3 square millimeter per second
Standard Error 0.0905
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
Participants With pSS
n=13 Participants
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).
|
Healthy Participants
n=12 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)
|
|---|---|---|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Parotid Gland, Low, IQR, n=12, 11
|
0.135 Ratio
Standard Error 0.0084
|
0.135 Ratio
Standard Error 0.0122
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Parotid Gland, High, IQR, n=12, 11
|
0.164 Ratio
Standard Error 0.0082
|
0.172 Ratio
Standard Error 0.0155
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Parotid Gland, Aggregated, IQR, n=12, 11
|
0.149 Ratio
Standard Error 0.0090
|
0.156 Ratio
Standard Error 0.0145
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Submandibular Gland, Low, IQR, n=12, 10
|
0.204 Ratio
Standard Error 0.0126
|
0.205 Ratio
Standard Error 0.0101
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Submandibular Gland, High, IQR, n=12, 10
|
0.233 Ratio
Standard Error 0.0143
|
0.233 Ratio
Standard Error 0.0102
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Submandibular Gland, Aggregated, IQR, n=12, 11
|
0.219 Ratio
Standard Error 0.0135
|
0.217 Ratio
Standard Error 0.0097
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Parotid Gland, Low, Median, n=12, 11
|
0.131 Ratio
Standard Error 0.0068
|
0.139 Ratio
Standard Error 0.0068
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Parotid Gland, High, Median, n=12, 11
|
0.151 Ratio
Standard Error 0.0098
|
0.164 Ratio
Standard Error 0.0127
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Parotid Gland, Aggregated, Median, n=12, 11
|
0.140 Ratio
Standard Error 0.0079
|
0.151 Ratio
Standard Error 0.0100
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Submandibular Gland, Low, Median, n=12, 10
|
0.198 Ratio
Standard Error 0.0164
|
0.238 Ratio
Standard Error 0.0263
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Submandibular Gland, High, Median, n=12, 10
|
0.223 Ratio
Standard Error 0.0167
|
0.271 Ratio
Standard Error 0.0257
|
|
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
Submandibular Gland, Aggregated, Median, n=12, 11
|
0.210 Ratio
Standard Error 0.0165
|
0.243 Ratio
Standard Error 0.0273
|
PRIMARY outcome
Timeframe: Visit 1: Within 6 weeks after BaselinePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
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.
Outcome measures
| Measure |
Participants With pSS
n=13 Participants
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).
|
Healthy Participants
n=12 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)
|
|---|---|---|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Parotid Gland, Low, Median, n=12, 12
|
5.598 Per minute
Standard Error 2.5910
|
3.326 Per minute
Standard Error 1.3677
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Parotid Gland, Low, IQR, n=12, 12
|
7.618 Per minute
Standard Error 3.8286
|
22.492 Per minute
Standard Error 9.8803
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Parotid Gland, High, IQR, n=12, 12
|
12.821 Per minute
Standard Error 6.7497
|
30.199 Per minute
Standard Error 13.2411
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Parotid Gland, Aggregated, IQR, n=12, 12
|
10.701 Per minute
Standard Error 5.5677
|
27.213 Per minute
Standard Error 12.3396
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Submandibular Gland, Low, IQR, n=9, 8
|
5.548 Per minute
Standard Error 4.6510
|
0.459 Per minute
Standard Error 0.0850
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Submandibular Gland, High, IQR, n=9, 8
|
15.192 Per minute
Standard Error 9.3625
|
19.914 Per minute
Standard Error 17.5121
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Submandibular Gland, Aggregated, IQR, n=11, 11
|
10.191 Per minute
Standard Error 6.1313
|
1.801 Per minute
Standard Error 0.8246
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Parotid Gland, High, Median, n=12, 12
|
8.841 Per minute
Standard Error 4.3542
|
9.323 Per minute
Standard Error 4.9569
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Parotid Gland, Aggregated, Median, n=12, 12
|
7.061 Per minute
Standard Error 3.4227
|
7.450 Per minute
Standard Error 3.8203
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Submandibular Gland, Low, Median, n=9, 8
|
12.789 Per minute
Standard Error 11.7785
|
0.775 Per minute
Standard Error 0.2742
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Submandibular Gland, High, Median, n=9, 8
|
17.315 Per minute
Standard Error 12.2640
|
1.606 Per minute
Standard Error 0.5826
|
|
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Submandibular Gland, Aggregated, Median, n=11,11
|
12.146 Per minute
Standard Error 9.8325
|
1.421 Per minute
Standard Error 0.6603
|
SECONDARY outcome
Timeframe: 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-injectionPopulation: PK Population
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.
Outcome measures
| Measure |
Participants With pSS
n=8 Participants
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).
|
Healthy Participants
n=12 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)
|
|---|---|---|
|
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Parotid Gland, Low
|
0.0574 Milliliter/centimeter cube/minute
Standard Deviation 0.02282
|
0.0425 Milliliter/centimeter cube/minute
Standard Deviation 0.02200
|
|
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Parotid Gland, High
|
0.0608 Milliliter/centimeter cube/minute
Standard Deviation 0.02411
|
0.0472 Milliliter/centimeter cube/minute
Standard Deviation 0.02293
|
|
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Parotid Gland, Aggregated
|
0.0593 Milliliter/centimeter cube/minute
Standard Deviation 0.02332
|
0.0448 Milliliter/centimeter cube/minute
Standard Deviation 0.02211
|
|
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Submandibular Gland, Low
|
0.0598 Milliliter/centimeter cube/minute
Standard Deviation 0.02051
|
0.0383 Milliliter/centimeter cube/minute
Standard Deviation 0.01756
|
|
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Submandibular Gland, High
|
0.0626 Milliliter/centimeter cube/minute
Standard Deviation 0.02137
|
0.0422 Milliliter/centimeter cube/minute
Standard Deviation 0.01916
|
|
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Submandibular Gland, Aggregated
|
0.0614 Milliliter/centimeter cube/minute
Standard Deviation 0.02085
|
0.0407 Milliliter/centimeter cube/minute
Standard Deviation 0.01863
|
SECONDARY outcome
Timeframe: 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-injectionPopulation: PK Population
Blood samples were collected at indicated time points for analysis. Pearson's correlation is presented along with 95% confidence interval.
Outcome measures
| Measure |
Participants With pSS
n=8 Participants
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).
|
Healthy Participants
n=12 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)
|
|---|---|---|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Max SUV, Low
|
-0.066 Grams per milliliter
Interval -0.736 to 0.67
|
0.915 Grams per milliliter
Interval 0.719 to 0.976
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Max SUV, High
|
-0.106 Grams per milliliter
Interval -0.754 to 0.647
|
0.884 Grams per milliliter
Interval 0.629 to 0.967
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Max SUV, Aggregated
|
-0.100 Grams per milliliter
Interval -0.752 to 0.65
|
0.891 Grams per milliliter
Interval 0.648 to 0.969
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Mean SUV, Low
|
0.142 Grams per milliliter
Interval -0.625 to 0.77
|
0.895 Grams per milliliter
Interval 0.66 to 0.97
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Mean SUV, High
|
0.130 Grams per milliliter
Interval -0.633 to 0.764
|
0.786 Grams per milliliter
Interval 0.387 to 0.937
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Peak SUV, Low
|
0.045 Grams per milliliter
Interval -0.681 to 0.727
|
0.929 Grams per milliliter
Interval 0.761 to 0.98
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Peak SUV, High
|
0.053 Grams per milliliter
Interval -0.677 to 0.73
|
0.866 Grams per milliliter
Interval 0.582 to 0.962
|
|
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Peak SUV, Aggregated
|
0.038 Grams per milliliter
Interval -0.685 to 0.723
|
0.906 Grams per milliliter
Interval 0.692 to 0.974
|
Adverse Events
Healthy Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants With pSS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Participants
n=13 participants at risk
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)
|
Participants With pSS
n=12 participants at risk
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).
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Non-serious adverse events and serious adverse events (SAE) were collected up to 11 weeks
Non-serious adverse events and SAEs were collected for Safety Population
|
8.3%
1/12 • Number of events 2 • Non-serious adverse events and serious adverse events (SAE) were collected up to 11 weeks
Non-serious adverse events and SAEs were collected for Safety Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER