NIR Fluorescence Imaging of Lymphatic Transport Using ICG

NCT02680067 | Completed Phase 1 FDA Drug

• 2 other identifiers: RSRB 54038R01AR056702
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Rheumatoid Arthritis

Keywords

Healthy Individual; Lymphatic Transport; Near InfraRed; Imaging; Indocyanine Green; ICG; NIR; NIR-ICG; MSImager; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lymphatic Pressure

  36 months

Other Outcomes (2)

• Clearance

  36 months

• Lymphatic Speed

  36 months

Study Arms (2)

Developmental arm - Healthy or rheumatoid arthritis subjects

EXPERIMENTAL

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.

Drug: Indocyanine Green; Device: MultiSpectral Imaging System

Clearance arm - Healthy individuals

EXPERIMENTAL

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.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.

Also known as: ICG, IC-Green, 17478-701-02

Clearance arm - Healthy individuals; Developmental arm - Healthy or rheumatoid arthritis subjects

MultiSpectral Imaging System DEVICE

Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.

Also known as: MSImager

Developmental arm - Healthy or rheumatoid arthritis subjects

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Rahimi H, Bell R, Bouta EM, Wood RW, Xing L, Ritchlin CT, Schwarz EM. Lymphatic imaging to assess rheumatoid flare: mechanistic insights and biomarker potential. Arthritis Res Ther. 2016 Sep 1;18:194. doi: 10.1186/s13075-016-1092-0.

  PMID: 27586634 DERIVED

Related Links

• Allergy, Immunology, and Rheumatology Clinical Trials

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Christopher Ritchlin, MD/MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.; Professor of Medicine, Chief of Allergy, Immunology & Rheumatology Division

Model Details: Healthy individuals and subjects that have rheumatoid arthritis may participate in the developmental arm. Healthy individuals may participate in the clearance arm. There will be no randomization.

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: February 11, 2016
• Study Start: December 8, 2015
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)