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Fluorescent Dye
Developmental arm - Healthy or rheumatoid arthritis subjects for Rheumatoid Arthritis (NIR-ICG Trial)
Phase 1
Waitlist Available
Led By Christopher Ritchlin, MD/MPH
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
NIR-ICG Trial Summary
This study is evaluating whether a new imaging technique can be used to evaluate lymphatic transport.
Eligible Conditions
- Rheumatoid Arthritis
NIR-ICG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Contraction Rate
Secondary outcome measures
Lymphatic Pressure
Other outcome measures
Clearance
Lymphatic Speed
NIR-ICG Trial Design
2Treatment groups
Experimental Treatment
Group I: Developmental arm - Healthy or rheumatoid arthritis subjectsExperimental Treatment2 Interventions
Subjects in the developmental arm will have a minimum of two study visits to determine the optimal conditions for visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities may be performed after the ICG fluorescence is observed. The exam will help identify the location of the lymphatic vessels and nodes in the areas fluoresced.
Group II: Clearance arm - Healthy individualsExperimental Treatment1 Intervention
Subjects in the clearance arm will have an initial study visit that involves injections of 0.1 mg/ml of Indocyanine Green (ICG) intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). Follow up imaging sessions will occur weekly for three weeks for a minimum of four study visits total.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MultiSpectral Imaging System
2019
Completed Phase 1
~30
Indocyanine Green
2008
Completed Phase 2
~1050
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of RochesterLead Sponsor
837 Previous Clinical Trials
518,094 Total Patients Enrolled
5 Trials studying Rheumatoid Arthritis
85 Patients Enrolled for Rheumatoid Arthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,086,984 Total Patients Enrolled
44 Trials studying Rheumatoid Arthritis
560,984 Patients Enrolled for Rheumatoid Arthritis
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,516 Total Patients Enrolled
9 Trials studying Rheumatoid Arthritis
625 Patients Enrolled for Rheumatoid Arthritis
Frequently Asked Questions
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