Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage

Study Overview
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Brief Summary
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To observe the relationship between the activity of rheumatoid arthritis and popliteal/epitrochlear lymph node morphology and the drainage of hand/foot superficial lymphatic vessels

Detailed Description
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Rheumatoid Arthritis patients and health participants will be recruited in our research. Then the classification of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 will be used to identify rheumatoid arthritis patients. The measurement of disease activity are Disease Activity Score 28 (DAS28) combined with the synovitis, bone edema and bone erosion of hand and wrist detected by magnetic resonance (MR) and Doppler ultrasound (DUS).The morphology of lymph node in popliteal/epitrochlear are scanned by 3-dimensional MR and DUS. The drainage of hand/foot superficial lymphatic vessels are detected in sight of near infrared ray (NIR) with the applying of Indocyanine Green (ICG) subcutaneously. We'll conduct correlation analysis to reveal the relationship between the activity of Rheumatoid Arthritis and lymph nodes morphology and lymphatic vessels drainage.

Official Title
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the Relationship Between the Activity of Rheumatoid Arthritis（RA） and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels

Conditions
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Rheumatoid Arthritis, Lymph Node Mass, Lymphatic Vessel; Dilatation

Intervention / Treatment
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* Drug: indocyanine green(ICG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points) Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history Age 18 to 65 years Fulling understood the whole trial and written informed consent. Exclusion Criteria: Participants will be excluded when they combined with: other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc., lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders, disorders that effect the circulation of lymph or blood vessels such as hemangiomas, tumors or cancer, operation history within a year, such as joint orthopedics, tumor resection, etc., allergies or allergic to iodine, or radioactive iodine treatment within the last year, with metal objects inside, such as pacemakers or nails, the skin for the ultrasound inspection not intact such as eczema,ulceration, etc., lactation or pregnancy women or preparation to be pregnant within the next half year, without whole limbs to inspect, mania, depression or other mental disorder medical disorders such as diabetes, hypertension or hyperlipidemia, etc., a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc., a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc., severe liver or kidney dysfunction (Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) two times higher than the upper limit of normal, serum creatinine levels more than two times the upper limit of normal); poor compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the patients group<br>0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR | Drug: indocyanine green(ICG)<br>* ICG will be injected into the dorsal of hand/foot<br>* Other names: IC-GREEN®(indocyanine green for injection,USP),AKORN,Inc;|
| the health group<br>0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR | Drug: indocyanine green(ICG)<br>* ICG will be injected into the dorsal of hand/foot<br>* Other names: IC-GREEN®(indocyanine green for injection,USP),AKORN,Inc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-initial | the time that it takes for the ICG to be detected in vessels | after the injection of ICG from the first day to the fourth day after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S-max | the maximum ICG signal intensity observed in the target lymph node during the first day imaging session | after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after | 
| T-max | the time it takes for a nodes in cubital fossa or popliteal space to achieve maximal ICG signal intensity | after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after | 
| %Clearance | an assessment of ICG wash out through the lymphatics and is quantified as the percent difference of ICG signal intensity between the two ICG-NIR images from a certain region at a) S-max (first day) and b) 24 hours post ICG injection, | after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after | 
| Pulse | ICG pulses that pass the a certain region within 400 seconds. | after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after | 
| lymphatic node size |  | the second day after enrollment | 
| lymphatic node shape |  | the second day after enrollment | 
| lymphatic node transverse/longitudinal diameter ratio |  | the second day after enrollment | 
| lymphatic node types of edges |  | the second day after enrollment | 
| lymphatic node thickness of cortex/medulla |  | the second day after enrollment | 
| lymphatic node homogeneity |  | the second day after enrollment | 
| lymphatic node hilum |  | the second day after enrollment | 
| lymphatic node blood flow signal |  | the second day after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, lymph nodes morphology, drainage of lymphatic vessels