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

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

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

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Lymph Node Mass; Lymphatic Vessel; Dilatation
• Intervention / Treatment: Drug: indocyanine green(ICG)

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 Type: Observational
• Enrollment (Anticipated): 21

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Longhua Hospital, Shanghai university of TCM
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital, Shanghai university of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study conducted in Shanghai, China. The participants will be recruited by advertisement in in Longhua hospital, communities and universities in Shanghai.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (ESTIMATE): August 24, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 24, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; lymph nodes morphology; drainage of lymphatic vessels
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: RA and lymphatic vessels

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO