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

Overview

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

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

Detailed Description

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.

Interventions

  • Drug: indocyanine green(ICG)
    • ICG will be injected into the dorsal of hand/foot

Arms, Groups and Cohorts

  • the patients group
    • 0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR
  • the health group
    • 0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • S-max
    • Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
    • the maximum ICG signal intensity observed in the target lymph node during the first day imaging session
  • T-max
    • Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
    • the time it takes for a nodes in cubital fossa or popliteal space to achieve maximal ICG signal intensity
  • %Clearance
    • Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
    • 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,
  • Pulse
    • Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
    • ICG pulses that pass the a certain region within 400 seconds.
  • lymphatic node size
    • Time Frame: the second day after enrollment
  • lymphatic node shape
    • Time Frame: the second day after enrollment
  • lymphatic node transverse/longitudinal diameter ratio
    • Time Frame: the second day after enrollment
  • lymphatic node types of edges
    • Time Frame: the second day after enrollment
  • lymphatic node thickness of cortex/medulla
    • Time Frame: the second day after enrollment
  • lymphatic node homogeneity
    • Time Frame: the second day after enrollment
  • lymphatic node hilum
    • Time Frame: the second day after enrollment
  • lymphatic node blood flow signal
    • Time Frame: the second day after enrollment

Participating in This Clinical Trial

Inclusion Criteria

1. Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points) 2. Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history 3. Age 18 to 65 years 4. Fulling understood the whole trial and written informed consent. Exclusion Criteria:

Participants will be excluded when they combined with: 1. other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc., 2. lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders, 3. disorders that effect the circulation of lymph or blood vessels such as hemangiomas, 4. tumors or cancer, 5. operation history within a year, such as joint orthopedics, tumor resection, etc., 6. allergies or allergic to iodine, or radioactive iodine treatment within the last year, 7. with metal objects inside, such as pacemakers or nails, 8. the skin for the ultrasound inspection not intact such as eczema,ulceration, etc., 9. lactation or pregnancy women or preparation to be pregnant within the next half year, 10. without whole limbs to inspect, 11. mania, depression or other mental disorder 12. medical disorders such as diabetes, hypertension or hyperlipidemia, etc., 13. a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc., 14. a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc., 15. 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); 16. poor compliance.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shanghai University of Traditional Chinese Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yong-jun Wang, Dr., Principal Investigator, Longhua Hospital
  • Overall Contact(s)
    • Qianqian Liang, Dr., 86-021-64875390, liangqianqiantcm@126.com

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