NIR Fluorescence Imaging of Lymphatic Transport Using ICG

• 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
• 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 Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institutes of Health (NIH)