RECRUITING

Imaging of Lymphatic Vessels in People with Rheumatoid Arthritis (RA)

Conditions

Rheumatoid Arthritis Near InfraRed Lymphatic Transport Imaging Indocyanine Green ICG MSImager

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Lymphatic transport was previously examined by these investigators using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities. They established reliable and reproducible methodologies in RA patients. The purpose of this phase 2 pilot is to study RA disease progression and effectiveness as well as the mechanism of action of clinical interventions using established NIR-ICG methodologies in previous studies.

Official Title

Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green: Phase II Pilot

Quick Facts

Study Start:2021-12-30

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05197530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Ability to provide written informed consent * Subjects must be 18 years old or older * RA subjects must fulfill 2010 American College of Rheumatology (ACR) criteria with a DAS28-C-Reactive Protein (CRP) \>3.5 * Must have 1 year or less of disease * Must be MTX inadequate responder (DAS28-CRP \>2.6 at 4 months of therapy) OR experience a flare on MTX (self-reported and score of \>25 on the Outcome Measures in Rheumatology (OMERACT) Flare questionnaire AND are starting an anti-TNF therapy. * Must have active synovitis in one or both hands confirmed by ultrasound * Ability to provide written informed consent * Subjects must be 18 years of age or older * RA subjects must fulfill 2010 ACR criteria with a DAS-CRP \>3.5 * Must have at least 10 years of disease * Must have active synovitis in one or both hands confirmed by ultrasound * Must be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine), Janus Kinase (JAK) inhibitor or biologic agent for 8 weeks	* Active systemic disorders or inflammatory conditions other than RA, (i.e., 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; pregnancy tests will not be performed * Inability to donate blood due to poor venous access

Inclusion Criteria

Exclusion Criteria

* Ability to provide written informed consent
* Subjects must be 18 years old or older
* RA subjects must fulfill 2010 American College of Rheumatology (ACR) criteria with a DAS28-C-Reactive Protein (CRP) \>3.5
* Must have 1 year or less of disease
* Must be MTX inadequate responder (DAS28-CRP \>2.6 at 4 months of therapy) OR experience a flare on MTX (self-reported and score of \>25 on the Outcome Measures in Rheumatology (OMERACT) Flare questionnaire AND are starting an anti-TNF therapy.
* Must have active synovitis in one or both hands confirmed by ultrasound
* Ability to provide written informed consent
* Subjects must be 18 years of age or older
* RA subjects must fulfill 2010 ACR criteria with a DAS-CRP \>3.5
* Must have at least 10 years of disease
* Must have active synovitis in one or both hands confirmed by ultrasound
* Must be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine), Janus Kinase (JAK) inhibitor or biologic agent for 8 weeks

* Active systemic disorders or inflammatory conditions other than RA, (i.e., 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; pregnancy tests will not be performed
* Inability to donate blood due to poor venous access

Contacts and Locations

Study Contact

Joseph Solomon, BS

CONTACT

585-275-1634

joseph_solomon@urmc.rochester.edu

Principal Investigator

Christopher Ritchlin, MD, MPH

PRINCIPAL_INVESTIGATOR

University of Rochester

Study Locations (Sites)

University of Rochester

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Christopher Ritchlin, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-30

Study Completion Date2025-06

Study Record Updates

Study Start Date2021-12-30

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

Near InfraRed
Lymphatic Transport
Imaging
Indocyanine Green
ICG
Rheumatoid Arthritis
MSImager

Additional Relevant MeSH Terms

Rheumatoid Arthritis