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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02876874
• Other study ID #: RA and lymphatic vessels
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2015
• Last updated: August 18, 2016
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Qianqian Liang, Dr.
• Phone: 86-021-64875390
• Email: liangqianqiantcm[@]126.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• indocyanine green(ICG)
ICG will be injected into the dorsal of hand/foot

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of TCM	Shanghai	Shanghai
China	Longhua Hospital, Shanghai University of TCM	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	%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	No
Secondary	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	No
Secondary	lymphatic node size		the second day after enrollment	No
Secondary	lymphatic node shape		the second day after enrollment	No
Secondary	lymphatic node transverse/longitudinal diameter ratio		the second day after enrollment	No
Secondary	lymphatic node types of edges		the second day after enrollment	No
Secondary	lymphatic node thickness of cortex/medulla		the second day after enrollment	No
Secondary	lymphatic node homogeneity		the second day after enrollment	No
Secondary	lymphatic node hilum		the second day after enrollment	No
Secondary	lymphatic node blood flow signal		the second day after enrollment	No