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CompletedNCT02899377Updated Oct 25, 2019Results posted

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

An interventional study of 18F-FDG PET/CT Imaging and 11C-MET PET/CT Imaging in Autoimmune Diseases, sponsored by GlaxoSmithKline. Completed at 4 sites in United Kingdom. Open to participants aged 30 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autoimmune Diseases

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Keywords

  • PET/CT
  • Primary Sjögren's Syndrome
  • Magnetic resonance imaging
  • 11^C-MET
  • 18^F-FDG
03

In context

Autoimmune Diseases

672 studies on the registry are indexed under Autoimmune Diseases; 272 are open to participants now.

This study's enrollment of 25 is below the median of 44 across 433 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Group A: Health subjects

    During Visit 1, these subjects will undergo the following: An MRI of the salivary glands with one-time intravenous (IV) bolus injection of 0.1 mmol/kg of gadoterate meglumine and receive one-time IV bolus injection of 500 megabecquerels (MBq) of 11C MET followed by a PET/CT (dynamic scan of the salivary glands followed by head to hip static scan)

    Radiation: 11C-MET PET/CT Imaging · Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine

  • Experimental
    Group B: pSS subjects

    During Visit 1, subjects with pSS will undergo the following: An MRI of the salivary glands with IV bolus injection of \<=0.1 mmol/kg of gadoterate meglumine and receive one-time IV bolus injections: 500 MBq of 11C-MET (PET/CT: as for Group A) and 200 MBq of 18F-FDG followed by a PET/CT (static head to hip scan)

    Radiation: 18F-FDG PET/CT Imaging · Radiation: 11C-MET PET/CT Imaging · Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine · Procedure: Minor Salivary gland (labial) biopsy

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Secondary outcomes

  1. 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

  2. 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

07

Results

Posted Oct 25, 2019

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.

Participant flow — Overall Study
MilestoneHealthy ParticipantsParticipants With pSS
Started1312
Completed1212
Not completed10
Withdrew: Adverse event10

Outcome measures

PrimaryStandardized 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
Reported as:
Mean · Grams per milliliter
Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas
Grams per milliliterParticipants With pSS
Aorta, Max SUV2.9067 ± 0.49445
Liver, Max SUV5.0683 ± 1.13564
Lumbar Vertebra, Max SUV4.0225 ± 0.91105
Muscle, Max SUV1.4558 ± 0.50282
Pancreas, Max SUV4.2700 ± 1.02711
Salivary gland, Max SUV3.1067 ± 0.83496
Spleen, Max SUV3.2333 ± 0.54135
Thyroid, Max SUV3.1408 ± 0.72742
Aorta, Mean SUV1.883 ± 0.2740
Liver, Mean SUV2.273 ± 0.2605
Lumbar Vertebra, Mean SUV2.105 ± 0.4000
Muscle, Mean SUV0.657 ± 0.1696
Pancreas, Mean SUV1.874 ± 0.2511
Spleen, Mean SUV1.751 ± 0.1889
Thyroid, Mean SUV1.822 ± 0.5509
Aorta, Peak SUV2.0125 ± 0.35028
Liver, Peak SUV3.2700 ± 0.53533
Lumbar Vertebra, Peak SUV2.8242 ± 0.58906
Muscle, Peak SUV0.8833 ± 0.25378
Pancreas, Peak SUV2.6892 ± 0.47389
Salivary gland, Peak SUV2.1425 ± 0.58856
Spleen, Peak SUV2.3475 ± 0.30266
Thyroid, Peak SUV2.2458 ± 0.68193
PrimarySUV 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
Reported as:
Mean · Grams per milliliter
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
Grams per milliliterParticipants With pSS
Lachrymal gland, Low, Max SUV1.7808 ± 0.38311
Lachrymal gland, High, Max SUV2.0658 ± 0.34849
Lachrymal gland, Aggregated, Max SUV2.0658 ± 0.34849
Parotid gland, Low, Max SUV2.5767 ± 0.68672
Parotid gland, High, Max SUV2.7783 ± 0.76902
Parotid gland, Aggregated, Max SUV2.7783 ± 0.76902
Submandibular gland, Low, Max SUV2.5200 ± 0.82131
Submandibular gland, High, Max SUV2.9250 ± 0.94362
Submandibular gland, Aggregated, Max SUV2.9250 ± 0.94362
Lachrymal gland, Low, Mean SUV1.311 ± 0.3218
Lachrymal gland, High, Mean SUV1.515 ± 0.2934
Parotid gland, Low, Mean SUV1.620 ± 0.5022
Parotid gland, High, Mean SUV1.818 ± 0.5957
Submandibular gland, Low, Mean SUV1.709 ± 0.6786
Submandibular gland, High, Mean SUV1.916 ± 0.6237
Lachrymal gland, Low, Peak SUV1.5842 ± 0.18535
Lachrymal gland, High, Peak SUV1.7125 ± 0.24264
Lachrymal gland, Aggregated, Peak SUV1.6492 ± 0.20505
Parotid gland, Low, Peak SUV2.0150 ± 0.64590
Parotid gland, High, Peak SUV2.2383 ± 0.71837
Parotid gland, Aggregated, Peak SUV2.1275 ± 0.67216
Submandibular gland, Low, Peak SUV1.9275 ± 0.74620
Submandibular gland, High, Peak SUV2.3883 ± 0.69049
Submandibular gland, Aggregated, Peak SUV2.1583 ± 0.67168
PrimaryTissue 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
Reported as:
Mean · Ratio
Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants
RatioParticipants With pSS
Aorta1.0660 ± 0.05729
Liver1.7366 ± 0.11645
Lumbar Vertebra1.5096 ± 0.28568
Muscle0.4669 ± 0.10222
Pancreas1.4312 ± 0.16490
Salivary gland1.1730 ± 0.38592
Spleen1.2625 ± 0.17400
Thyroid1.2193 ± 0.44934
PrimaryTR 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
Reported as:
Mean · Ratio
TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants
RatioParticipants With pSS
Lachrymal gland, Low0.8529 ± 0.12250
Lachrymal gland, High0.9201 ± 0.13587
Lachrymal gland, Aggregated0.8864 ± 0.12560
Parotid gland, Low1.1158 ± 0.44262
Parotid gland, High1.2338 ± 0.47055
Parotid gland, Aggregated1.1749 ± 0.45273
Submandibular gland, Low1.0472 ± 0.43105
Submandibular gland, High1.2953 ± 0.41063
Submandibular gland, Aggregated1.1711 ± 0.40012
PrimaryTotal 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

No measurements were reported for this outcome.

PrimarySUV 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
Reported as:
Mean · Grams per milliliter
SUV for 11C- MET in Selected Body Areas
Grams per milliliterParticipants With pSSHealthy Participants
Aorta, Max SUV2.2700 ± 0.727092.0275 ± 0.62609
Liver, Max SUV19.1667 ± 3.8178316.4213 ± 3.31237
Lumbar Vertebra, Max SUV7.1733 ± 2.853825.9100 ± 1.43376
Muscle, Max SUV2.4167 ± 0.898792.3513 ± 1.01454
Pancreas, Max SUV31.4492 ± 5.1791131.7388 ± 5.68871
Salivary gland, Max SUV5.4275 ± 1.430536.6900 ± 1.05224
Spleen, Max SUV5.5100 ± 1.357005.2750 ± 1.22413
Thyroid, Max SUV3.7058 ± 0.864503.1038 ± 0.79784
Aorta, Mean SUV1.161 ± 0.29271.029 ± 0.3334
Liver, Mean SUV10.926 ± 2.16928.916 ± 1.4380
Lumbar Vertebra, Mean SUV3.485 ± 0.93512.923 ± 0.5387
Muscle, Mean SUV0.968 ± 0.20740.926 ± 0.2365
Pancreas, Mean SUV16.413 ± 3.100816.556 ± 2.9023
Spleen, Mean SUV2.650 ± 0.37452.423 ± 0.1005
Thyroid, Mean SUV2.149 ± 0.64181.646 ± 0.3138
Aorta, Peak SUV1.3250 ± 0.375901.1338 ± 0.41008
Liver, Peak SUV14.7808 ± 3.0166612.3438 ± 1.76812
Lumbar Vertebra, Peak SUV4.7317 ± 1.281053.8775 ± 0.62923
Muscle, Peak SUV1.3675 ± 0.406561.3100 ± 0.29544
Pancreas, Peak SUV26.4683 ± 4.2960826.7913 ± 6.21700
Salivary gland, Peak SUV3.3633 ± 1.166245.0600 ± 0.83111
Spleen, Peak SUV3.6975 ± 0.615563.4100 ± 0.35633
Thyroid, Peak SUV2.6000 ± 0.654482.0525 ± 0.29673
PrimarySUV 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
Reported as:
Mean · Grams per milliliter
SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET
Grams per milliliterParticipants With pSSHealthy Participants
Lachrymal gland, Low, Max SUV1.9133 ± 1.004692.5513 ± 1.00049
Lachrymal gland, High, Max SUV2.1483 ± 1.022053.1250 ± 1.49196
Lachrymal gland, Aggregated, Max SUV2.1483 ± 1.022053.1250 ± 1.49196
Parotid gland, Low, Max SUV4.3933 ± 1.310725.9038 ± 1.01547
Parotid gland, High, Max SUV4.9492 ± 1.224156.3750 ± 1.09929
Parotid gland, Aggregated, Max SUV4.9492 ± 1.224156.3750 ± 1.09929
Submandibular gland, Low, Max SUV3.8583 ± 1.784846.2150 ± 1.06158
Submandibular gland, High, Max SUV4.4692 ± 1.778726.5488 ± 0.94266
Submandibular gland, Aggregated, Max SUV4.4692 ± 1.778726.5488 ± 0.94266
Lachrymal gland, Low, Mean SUV1.312 ± 0.60481.703 ± 0.5810
Lachrymal gland, High, Mean SUV1.462 ± 0.64902.056 ± 0.7874
Parotid gland, Low, Mean SUV2.525 ± 0.87403.505 ± 0.5637
Parotid gland, High, Mean SUV2.925 ± 0.86793.648 ± 0.5709
Submandibular gland, Low, Mean SUV2.388 ± 1.18553.923 ± 0.4941
Submandibular gland, High, Mean SUV2.648 ± 1.21284.191 ± 0.5410
Lachrymal gland, Low, Peak SUV1.3525 ± 0.597151.7738 ± 0.66125
Lachrymal gland, High, Peak SUV1.4958 ± 0.656262.1688 ± 0.99580
Lachrymal gland, Aggregated, Peak SUV1.4233 ± 0.622221.9713 ± 0.81354
Parotid gland, Low, Peak SUV3.4367 ± 1.227484.9000 ± 0.92893
Parotid gland, High, Peak SUV3.9175 ± 1.182555.1663 ± 0.85276
Parotid gland, Aggregated, Peak SUV3.6767 ± 1.187925.0325 ± 0.89020
Submandibular gland, Low, Peak SUV2.8025 ± 1.531964.8588 ± 0.86087
Submandibular gland, High, Peak SUV3.2992 ± 1.631675.3100 ± 0.89113
Submandibular gland, Aggregated, Peak SUV3.0517 ± 1.563595.0838 ± 0.86490
PrimaryTR 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
Reported as:
Mean · Ratio
TR Ratio for 11C- MET
RatioParticipants With pSSHealthy Participants
Aorta1.1352 ± 0.067381.0910 ± 0.04942
Liver13.1513 ± 3.1357212.8649 ± 3.46136
Lumbar Vertebra4.1158 ± 0.853143.9731 ± 0.80867
Muscle1.1914 ± 0.268021.3354 ± 0.34831
Pancreas23.5403 ± 4.6214029.8331 ± 15.21426
Salivary gland3.0974 ± 1.301055.2805 ± 1.44642
Spleen3.2872 ± 0.674703.5414 ± 0.81253
Thyroid2.3002 ± 0.631422.1213 ± 0.49670
PrimaryTR 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
Reported as:
Mean · Ratio
TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland
RatioParticipants With pSSHealthy Participants
Lachrymal gland, Low1.2007 ± 0.556391.8219 ± 0.62711
Lachrymal gland, High1.3178 ± 0.591152.1965 ± 0.76588
Lachrymal gland, Aggregated1.2594 ± 0.571882.0094 ± 0.68084
Parotid gland, Low3.1810 ± 1.445255.1570 ± 1.61371
Parotid gland, High3.6198 ± 1.413385.4621 ± 1.73285
Parotid gland, Aggregated3.4003 ± 1.415425.3096 ± 1.67006
Submandibular gland, Low2.5766 ± 1.616825.0230 ± 1.20994
Submandibular gland, High3.0126 ± 1.619825.4796 ± 1.30126
Submandibular gland, Aggregated2.7946 ± 1.605785.2513 ± 1.24653
PrimaryTotal 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

No measurements were reported for this outcome.

PrimaryMulti-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
Reported as:
Mean · 10^-3 square millimeter per second
Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)
10^-3 square millimeter per secondHealthy ParticipantsParticipants With pSS
Parotid Gland, Low, IQR, n=12, 110.511 ± 0.03140.516 ± 0.0356
Parotid Gland, High, IQR, n=12, 110.581 ± 0.02750.646 ± 0.0412
Parotid Gland, Aggregated, IQR, n=12, 110.544 ± 0.02640.582 ± 0.0408
Submandibular Gland, Low, IQR, n=12, 100.549 ± 0.03210.765 ± 0.0693
Submandibular Gland, High, IQR, n=12, 100.674 ± 0.03090.928 ± 0.0714
Submandibular Gland, Aggregated, IQR, n=12, 110.602 ± 0.03030.809 ± 0.0695
Parotid Gland, Low, Median, n=12, 111.091 ± 0.04761.011 ± 0.0607
Parotid Gland, High, Median, n=12, 111.153 ± 0.04511.117 ± 0.0524
Parotid Gland, Aggregated, Median, n=12, 111.120 ± 0.04601.069 ± 0.0539
Submandibular Gland, Low, Median, n=12, 101.469 ± 0.03771.410 ± 0.0924
Submandibular Gland, High, Median, n=12, 101.540 ± 0.04611.551 ± 0.0833
Submandibular Gland, Aggregated, Median, n=12, 111.506 ± 0.03961.474 ± 0.0767
PrimaryMulti-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
Reported as:
Mean · 10^-3 square millimeter per second
Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)
10^-3 square millimeter per secondHealthy ParticipantsParticipants With pSS
Parotid Gland, Low, IQR, n=12, 110.437 ± 0.03430.449 ± 0.0326
Parotid Gland, High, IQR, n=12, 110.503 ± 0.03360.529 ± 0.0296
Parotid Gland, Aggregated, IQR, n=12, 110.468 ± 0.03440.493 ± 0.0322
Submandibular Gland, Low, IQR, n=12, 100.553 ± 0.03610.547 ± 0.0440
Submandibular Gland, High, IQR, n=12, 100.733 ± 0.03770.681 ± 0.0641
Submandibular Gland, Aggregated, IQR, n=12, 110.636 ± 0.03240.608 ± 0.0443
Parotid Gland, Low, Median, n=12, 110.771 ± 0.02690.621 ± 0.0492
Parotid Gland, High, Median, n=12, 110.807 ± 0.02870.715 ± 0.0450
Parotid Gland, Aggregated, Median, n=12, 110.787 ± 0.02740.676 ± 0.0457
Submandibular Gland, Low, Median, n=12, 100.941 ± 0.04450.733 ± 0.0924
Submandibular Gland, High, Median, n=12, 101.035 ± 0.04020.814 ± 0.0887
Submandibular Gland, Aggregated, Median, n=12, 110.993 ± 0.04090.807 ± 0.0905
PrimaryMulti-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
Reported as:
Mean · Ratio
Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction
RatioHealthy ParticipantsParticipants With pSS
Parotid Gland, Low, IQR, n=12, 110.135 ± 0.00840.135 ± 0.0122
Parotid Gland, High, IQR, n=12, 110.164 ± 0.00820.172 ± 0.0155
Parotid Gland, Aggregated, IQR, n=12, 110.149 ± 0.00900.156 ± 0.0145
Submandibular Gland, Low, IQR, n=12, 100.204 ± 0.01260.205 ± 0.0101
Submandibular Gland, High, IQR, n=12, 100.233 ± 0.01430.233 ± 0.0102
Submandibular Gland, Aggregated, IQR, n=12, 110.219 ± 0.01350.217 ± 0.0097
Parotid Gland, Low, Median, n=12, 110.131 ± 0.00680.139 ± 0.0068
Parotid Gland, High, Median, n=12, 110.151 ± 0.00980.164 ± 0.0127
Parotid Gland, Aggregated, Median, n=12, 110.140 ± 0.00790.151 ± 0.0100
Submandibular Gland, Low, Median, n=12, 100.198 ± 0.01640.238 ± 0.0263
Submandibular Gland, High, Median, n=12, 100.223 ± 0.01670.271 ± 0.0257
Submandibular Gland, Aggregated, Median, n=12, 110.210 ± 0.01650.243 ± 0.0273
PrimaryMulti-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
Reported as:
Mean · Per minute
Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)
Per minuteHealthy ParticipantsParticipants With pSS
Parotid Gland, Low, IQR, n=12, 127.618 ± 3.828622.492 ± 9.8803
Parotid Gland, High, IQR, n=12, 1212.821 ± 6.749730.199 ± 13.2411
Parotid Gland, Aggregated, IQR, n=12, 1210.701 ± 5.567727.213 ± 12.3396
Submandibular Gland, Low, IQR, n=9, 85.548 ± 4.65100.459 ± 0.0850
Submandibular Gland, High, IQR, n=9, 815.192 ± 9.362519.914 ± 17.5121
Submandibular Gland, Aggregated, IQR, n=11, 1110.191 ± 6.13131.801 ± 0.8246
Parotid Gland, Low, Median, n=12, 125.598 ± 2.59103.326 ± 1.3677
Parotid Gland, High, Median, n=12, 128.841 ± 4.35429.323 ± 4.9569
Parotid Gland, Aggregated, Median, n=12, 127.061 ± 3.42277.450 ± 3.8203
Submandibular Gland, Low, Median, n=9, 812.789 ± 11.77850.775 ± 0.2742
Submandibular Gland, High, Median, n=9, 817.315 ± 12.26401.606 ± 0.5826
Submandibular Gland, Aggregated, Median, n=11,1112.146 ± 9.83251.421 ± 0.6603
SecondaryNet 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
Reported as:
Mean · Milliliter/centimeter cube/minute
Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT
Milliliter/centimeter cube/minuteHealthy ParticipantsParticipants With pSS
Parotid Gland, Low0.0574 ± 0.022820.0425 ± 0.02200
Parotid Gland, High0.0608 ± 0.024110.0472 ± 0.02293
Parotid Gland, Aggregated0.0593 ± 0.023320.0448 ± 0.02211
Submandibular Gland, Low0.0598 ± 0.020510.0383 ± 0.01756
Submandibular Gland, High0.0626 ± 0.021370.0422 ± 0.01916
Submandibular Gland, Aggregated0.0614 ± 0.020850.0407 ± 0.01863
SecondaryCorrelation 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
Reported as:
Number · Grams per milliliter
Correlation Between Static and Dynamic Imaging Metrics in 11C-MET
Grams per milliliterHealthy ParticipantsParticipants With pSS
Max SUV, Low-0.066 (-0.736 to 0.670)0.915 (0.719 to 0.976)
Max SUV, High-0.106 (-0.754 to 0.647)0.884 (0.629 to 0.967)
Max SUV, Aggregated-0.100 (-0.752 to 0.650)0.891 (0.648 to 0.969)
Mean SUV, Low0.142 (-0.625 to 0.770)0.895 (0.660 to 0.970)
Mean SUV, High0.130 (-0.633 to 0.764)0.786 (0.387 to 0.937)
Peak SUV, Low0.045 (-0.681 to 0.727)0.929 (0.761 to 0.980)
Peak SUV, High0.053 (-0.677 to 0.730)0.866 (0.582 to 0.962)
Peak SUV, Aggregated0.038 (-0.685 to 0.723)0.906 (0.692 to 0.974)

Adverse events

Collected over Non-serious adverse events and serious adverse events (SAE) were collected up to 11 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Participants0/13 (0%)0/13 (0%)1/13 (7.7%)
Participants With pSS0/12 (0%)0/12 (0%)1/12 (8.3%)
Most frequent other events
Most frequent other events
EventHealthy ParticipantsParticipants With pSS
HeadacheNervous system disorders1/131/12

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Healthy ParticipantsParticipants With pSSTotal
Mean48.1 ± 13.8749.0 ± 13.7048.5 ± 13.51
Sex: Female, Male
Sex: Female, Male(Participants)Healthy ParticipantsParticipants With pSSTotal
Female131225
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Count of Participants)Healthy ParticipantsParticipants With pSSTotal
Asian: Central/south Asian heritage033
Asian: South East Asian heritage011
Black or African American202
White/Caucasian/European Heritage10515
Mixed race White Caribbean101
Unknown022
Black British011
08

Study locations

4 sites
  • GSK Investigational Site
    Cambridge, CB2 0GG, United Kingdom
  • GSK Investigational Site
    London, E1 4DG, United Kingdom
  • GSK Investigational Site
    London, NW1 2PG, United Kingdom
  • GSK Investigational Site
    London, United Kingdom
09

References and documents

Study documents

  • Study protocol · May 24, 2017
  • Statistical analysis plan · Jun 8, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02899377
Lead sponsor
GlaxoSmithKline
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Sep 14, 2016
Start date
Nov 18, 2016
Primary completion
Jul 12, 2018
Completion
Jul 12, 2018
Results posted
Oct 25, 2019
Last update
Oct 25, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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