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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02876874
Recruitment Status : Unknown
Verified August 2016 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Rheumatoid Arthritis Lymph Node Mass Lymphatic Vessel; Dilatation 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 21 participants
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: 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 Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: IC-GREEN®(indocyanine green for injection,USP),AKORN,Inc




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. %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,

  4. 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.

  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 ]

Biospecimen Retention:   Samples Without DNA
Peripheral blood 10ml for the analysis of cytokines,such as IL-1/6, TNF-α,VEGF-3 recepter,VEGFRC/E, et al.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876874


Contacts
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Contact: Qianqian Liang, Dr. 86-021-64875390 liangqianqiantcm@126.com
Contact: Qiong Wang 86-13671779096 13671779096@163.com

Locations
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China, Shanghai
Longhua Hospital, Shanghai University of TCM Recruiting
Shanghai, Shanghai, China, 200032
Contact: Qianqian Liang, Doctor    86-021-64875390    liangqianqiantcm@126.com   
Contact: Qiong Wang    86-13671779096    13671779096@163.com   
Principal Investigator: Yongjun Wang, Doctor         
China
Longhua Hospital, Shanghai University of TCM Recruiting
Shanghai, China, 200032
Contact: Qianqian Liang, Doctor    86-021-64875390    liangqianqiantcm@126.com   
Contact: Qiong Wang    86-13671779096    13671779096@163.com   
Principal Investigator: Yongjun Wang, Doctor         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yong-jun Wang, Dr. Longhua Hospital
Additional Information:

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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02876874    
Other Study ID Numbers: RA and lymphatic vessels
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shanghai University of Traditional Chinese Medicine:
Rheumatoid Arthritis
lymph nodes morphology
drainage of lymphatic vessels
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases