Rheumatoid Arthritis Clinical Trial
— NIR-ICGOfficial title:
Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green
Verified date | October 2022 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this phase 1 study, the lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy individuals using a MultiSpectral Imaging System (MSImager).
Status | Completed |
Enrollment | 23 |
Est. completion date | July 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clearance | The change in Indocyanine Green signal intensity (arbitrary units) over time is measured by observing the fluorescence using the Multispectral Imaging System. The MSImager software analyses the signal intensity. | 36 months | |
Other | Lymphatic Speed | Speed with which an Indocyanine Green bolus moves through a lymphatic vessel recorded as mm -sec-1 using the Multispectral Imaging System. The MSImager software analyses the signal speed. | 36 months | |
Primary | Contraction Rate | The contraction rate is measured as lymphatic vessel contractions/min in the dominant lymphatic vessel efferent to the injection site using the MultiSpectral Imaging System (MSImager) that captures real time movies. The MSImager software analyses the signal intensity to determine the contraction rate. | 36 months | |
Secondary | Lymphatic Pressure | The lymphatic pressure is measured using a transparent cuff and the Multispectral Imaging System to determine indirect lymphatic pressure and recorded as mm Hg. | 36 months |
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