Rheumatoid ArthritisNCT02876874
Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage
An observational study of Rheumatoid Arthritis and Lymph Node Mass, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Lymph Node Mass, Lymphatic Vessel; Dilatation
- What is being tested?
- indocyanine green(ICG)
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2014to Dec 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study conducted in Shanghai, China. The participants will be recruited by advertisement in in Longhua hospital, communities and universities in Shanghai.
Who may be able to join
- Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points)
- Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history
- Age 18 to 65 years
- Fulling understood the whole trial and written informed consent.
Who cannot join
- Participants will be excluded when they combined with:
- other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc.,
- lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders,
- disorders that effect the circulation of lymph or blood vessels such as hemangiomas,
- tumors or cancer,
- operation history within a year, such as joint orthopedics, tumor resection, etc.,
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- allergies or allergic to iodine, or radioactive iodine treatment within the last year,
- with metal objects inside, such as pacemakers or nails,
- the skin for the ultrasound inspection not intact such as eczema,ulceration, etc.,
- lactation or pregnancy women or preparation to be pregnant within the next half year,
- without whole limbs to inspect,
- mania, depression or other mental disorder
- medical disorders such as diabetes, hypertension or hyperlipidemia, etc.,
- a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc.,
- a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc.,
- 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);
- poor compliance.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Qianqian Liang, Doctor, 86-021-64875390, liangqianqiantcm@126.com
Qiong Wang, 86-13671779096, 13671779096@163.com
- Recruiting
Longhua Hospital, Shanghai University of TCM
Shanghai, 200032
Qianqian Liang, Doctor, 86-021-64875390, liangqianqiantcm@126.com
Qiong Wang, 86-13671779096, 13671779096@163.com
About this study
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
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.
- Being tested
- indocyanine green(ICG)
- Keywords
- Rheumatoid Arthritis, lymph nodes morphology, drainage of lymphatic vessels
- Medical subject headings
- Arthritis, Rheumatoid, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green(ICG)Drug
Also called IC-GREEN®(indocyanine green for injection,USP),AKORN,Inc
ICG will be injected into the dorsal of hand/foot
| Study group | Role | What they receive |
|---|---|---|
| the patients group | 0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR Receives: Drug: indocyanine green(ICG) | |
| the health group | 0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR Receives: Drug: indocyanine green(ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
T-initial
the time that it takes for the ICG to be detected in vessels
Measured: after the injection of ICG from the first day to the fourth day after
Secondary outcomes (12)
S-max
the maximum ICG signal intensity observed in the target lymph node during the first day imaging session
Measured: 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
Measured: 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,
Measured: 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.
Measured: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
lymphatic node size
Measured: the second day after enrollment
lymphatic node shape
Measured: the second day after enrollment
lymphatic node transverse/longitudinal diameter ratio
Measured: the second day after enrollment
lymphatic node types of edges
Measured: the second day after enrollment
lymphatic node thickness of cortex/medulla
Measured: the second day after enrollment
lymphatic node homogeneity
Measured: the second day after enrollment
lymphatic node hilum
Measured: the second day after enrollment
lymphatic node blood flow signal
Measured: the second day after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong-jun Wang, Dr., Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876874
- Sponsor's protocol ID
- RA and lymphatic vessels
- Status last verified
- Aug 2016
- First submitted
- 3 Feb 2015
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02876874
- Acronym / sponsor ID
- RA and lymphatic vessels
- Keywords
- Rheumatoid Arthritis, lymph nodes morphology, drainage of lymphatic vessels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the patients group | – | Drug: indocyanine green(ICG)0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR |
| the health group | – | Drug: indocyanine green(ICG)0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study conducted in Shanghai, China. The participants will be recruited by advertisement in in Longhua hospital, communities and universities in Shanghai.
Key inclusion criteria (4 listed)
- Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points)
- Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history
- Age 18 to 65 years
- Fulling understood the whole trial and written informed consent.
Key exclusion criteria (17 listed)
- other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc.,
- lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders,
- disorders that effect the circulation of lymph or blood vessels such as hemangiomas,
- tumors or cancer,
- operation history within a year, such as joint orthopedics, tumor resection, etc.,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine green(ICG)Also: IC-GREEN®(indocyanine green for injection,USP),AKORN,IncICG will be injected into the dorsal of hand/foot | Drug | the health group, the patients group |
Primary outcome
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
12 secondary outcomes
S-max
Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
T-max
Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
%Clearance
Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
Pulse
Time frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
lymphatic node size
Time frame: the second day after enrollment
lymphatic node shape
Time frame: the second day after enrollment
lymphatic node transverse/longitudinal diameter ratio
Time frame: the second day after enrollment
lymphatic node types of edges
Time frame: the second day after enrollment
lymphatic node thickness of cortex/medulla
Time frame: the second day after enrollment
lymphatic node homogeneity
Time frame: the second day after enrollment
lymphatic node hilum
Time frame: the second day after enrollment
lymphatic node blood flow signal
Time frame: the second day after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong-jun Wang, Dr. principal investigator
Longhua Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Lymph Node Mass, run by Shanghai University of Traditional Chinese Medicine at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qianqian Liang, Dr. (86-021-64875390, liangqianqiantcm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-initial (time frame: after the injection of ICG from the first day to the fourth day after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2016.