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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02876874
Enrollment
21
Registered
2016-08-24
Start date
2014-12-31
Completion date
2018-12-31
Last updated
2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphatic Vessel; Dilatation, Lymph Node Mass, Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, lymph nodes morphology, drainage of lymphatic vessels

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.

Interventions

ICG will be injected into the dorsal of hand/foot

Sponsors

Shanghai University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
T-initialafter the injection of ICG from the first day to the fourth day afterthe time that it takes for the ICG to be detected in vessels

Secondary

MeasureTime frameDescription
T-maxafter the injection of ICG, 1day after, 2 days after, 3 days after and 4days afterthe time it takes for a nodes in cubital fossa or popliteal space to achieve maximal ICG signal intensity
%Clearanceafter the injection of ICG, 1day after, 2 days after, 3 days after and 4days afteran 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,
Pulseafter the injection of ICG, 1day after, 2 days after, 3 days after and 4days afterICG pulses that pass the a certain region within 400 seconds.
lymphatic node sizethe second day after enrollment
lymphatic node shapethe second day after enrollment
S-maxafter the injection of ICG, 1day after, 2 days after, 3 days after and 4days afterthe maximum ICG signal intensity observed in the target lymph node during the first day imaging session
lymphatic node types of edgesthe second day after enrollment
lymphatic node thickness of cortex/medullathe second day after enrollment
lymphatic node homogeneitythe second day after enrollment
lymphatic node hilumthe second day after enrollment
lymphatic node blood flow signalthe second day after enrollment
lymphatic node transverse/longitudinal diameter ratiothe second day after enrollment

Countries

China

Contacts

Primary ContactQianqian Liang, Dr.
liangqianqiantcm@126.com86-021-64875390
Backup ContactQiong Wang
13671779096@163.com86-13671779096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026