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

• Conditions: Lymph Node Mass; Lymphatic Vessel; Dilatation; Rheumatoid Arthritis
• Interventions: Drug: indocyanine green(ICG)

• Registration Number: NCT02876874
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-02-03
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-18
• Last Update Submitted: 2016-08-18
• Study First Posted: 2016-08-24
• Last Update Posted: 2016-08-24
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
T-initial	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 Outcome Measures

Name	Time	Method
T-max	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
S-max	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
%Clearance	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	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	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

Trial Locations

Locations (1)

Longhua Hospital, Shanghai University of TCM; 🇨🇳 Shanghai, China