A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome

GlaxoSmithKline1 个研究点分布在 1 个国家目标入组 25 人2016年11月18日

适应症Autoimmune Diseases

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Autoimmune Diseases
发起方: GlaxoSmithKline
入组人数: 25
试验地点: 1
主要终点: TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland
状态: 已完成
最后更新: 6年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2016年11月18日

结束日期

2018年7月12日

最后更新

6年前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

GlaxoSmithKline

责任方

Sponsor

入排标准

入选标准

•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.

排除标准

•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.