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Status unknownNCT02876874Updated Aug 24, 2016

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

An observational study in Rheumatoid Arthritis, Lymph Node Mass and Lymphatic Vessel; Dilatation, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 2 sites in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-24.

Sponsored by Shanghai University of Traditional Chinese Medicine · Observational

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
21
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Lymph Node Mass
  • Lymphatic Vessel; Dilatation

Keywords

  • Rheumatoid Arthritis
  • lymph nodes morphology
  • drainage of lymphatic vessels
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 21 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Time perspective
Prospective
Enrollment
21 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • the patients group

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

    Drug: indocyanine green(ICG)

  • the health group

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

    Drug: indocyanine green(ICG)

Interventions

  • Drugindocyanine green(ICG)

    ICG will be injected into the dorsal of hand/foot

    Also known as: IC-GREEN®(indocyanine green for injection,USP),AKORN,Inc

06

What researchers measure

Primary outcomes

  1. T-initial

    the time that it takes for the ICG to be detected in vessels

    Time frame: after the injection of ICG from the first day to the fourth day after

Secondary outcomes

  1. S-max

    the maximum ICG signal intensity observed in the target lymph node during the first day imaging session

    Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after

  2. T-max

    the time it takes for a nodes in cubital fossa or popliteal space to achieve maximal ICG signal intensity

    Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after

  3. %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,

    Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after

  4. Pulse

    ICG pulses that pass the a certain region within 400 seconds.

    Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after

  5. lymphatic node size

    Time frame: the second day after enrollment

  6. lymphatic node shape

    Time frame: the second day after enrollment

  7. lymphatic node transverse/longitudinal diameter ratio

    Time frame: the second day after enrollment

  8. lymphatic node types of edges

    Time frame: the second day after enrollment

  9. lymphatic node thickness of cortex/medulla

    Time frame: the second day after enrollment

  10. lymphatic node homogeneity

    Time frame: the second day after enrollment

  11. lymphatic node hilum

    Time frame: the second day after enrollment

  12. lymphatic node blood flow signal

    Time frame: the second day after enrollment

07

Study locations

2 of 2 sites recruiting
  • Longhua Hospital, Shanghai University of TCM
    Shanghai, Shanghai 200032, China
    Recruiting
  • Longhua Hospital, Shanghai University of TCM
    Shanghai, 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02876874
Lead sponsor
Shanghai University of Traditional Chinese Medicine
Responsible party
Sponsor
First posted
Aug 24, 2016
Start date
Dec 2014
Primary completion
Dec 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 24, 2016

Study contacts

Qianqian Liang, Dr.
Contact
liangqianqiantcm@126.com
86-021-64875390
Qiong Wang
Contact
13671779096@163.com
86-13671779096
Yong-jun Wang, Dr.
principal investigator · Longhua Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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