World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 31 October 2022
Main ID:  NCT02680067
Date of registration: 07/12/2015
Prospective Registration: Yes
Primary sponsor: University of Rochester
Public title: NIR Fluorescence Imaging of Lymphatic Transport Using ICG NIR-ICG
Scientific title: Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green
Date of first enrolment: December 8, 2015
Target sample size: 23
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02680067
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Contacts
Name:     Christopher Ritchlin, MD/MPH
Address: 
Telephone:
Email:
Affiliation:  University of Rochester
Key inclusion & exclusion criteria

Inclusion Criteria:

- Ability to provide written informed consent

- Subjects can be either gender but must be at least 18 years old.

- Rheumatoid arthritis subjects may fulfill 2010 American College of Rheumatology
criteria.

- Active rheumatoid arthritis subjects, with at least 2 tender or swollen joints.

- Subjects participating in the clearance arm of the study must not have ICG injections
for at least 10 weeks.

Exclusion Criteria:

- Individuals with active systemic disorders or inflammatory conditions other than
rheumatoid arthritis, (such as chronic infections with hepatitis B, hepatitis C or
HIV) that would confound the study results.

- Known sensitivity to iodine because of residual iodide in Indocyanine Green

- Pregnant women should not participate.



Age minimum: 18 Years
Age maximum: 89 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Device: MultiSpectral Imaging System
Drug: Indocyanine Green
Primary Outcome(s)
Contraction Rate [Time Frame: 36 months]
Secondary Outcome(s)
Lymphatic Pressure [Time Frame: 36 months]
Secondary ID(s)
RSRB 54038
R01AR056702
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey