Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport

NCT04046146 | Completed Phase 1 FDA Drug

• 1 other identifier: STUDY3891
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) and magnetic resonance lymphography (MRL) of the upper extremities. The purpose of the study is to establish if NIR-ICG is a valid clinical outcome for quantifying lymphatic vessel drainage.

Conditions

Rheumatoid Arthritis

Keywords

Healthy Volunteers; Lymphatic Transport; Imaging; Indocyanine Green; Gadolinium; ICG; GAD; NIR-ICG; rhuematoid arthritis; NIR

Outcome Measures

Primary Outcomes (3)

• Manual lymphatic vessel counts via assessment of 2D images of NIR-ICG compared to MRI. Unit of measure: # lymphatic vessels/hand

  Vessel location and numbers will be identified using 2D still images from the NIR scanning sessions and with 2D MR images. These images will be superimposed upon each other in order to confirm concordance of lymphatic vessels. Number of lymphatic vessels in the hands will be manually counted.

  12 months

• Lymphatic contraction rate measured via NIR ICG camera. Unit of measure: # contraction/minute

  Images collected from NIR scanning sessions will be analyzed to determine lymphatic contraction rate by identifying number of contractions per minute.

  12 months

• ICG clearance measured from hand using NIR ICG images. Unit of measure: (% difference Visit 1 from Visit 2)

  2D still images collected from NIR scanning sessions will be analyzed to determine ICG clearance by comparing the % difference from visit 1 to visit 2.

  12 months

Study Arms (1)

NIR-ICG MRL

EXPERIMENTAL

We may ask healthy subjects to return for up to four injection sessions for the study. The first injection session will consist of intradermal injection of ICG into the webspaces of the hand as done in our previous studies followed by NIR camera imaging. The second session will consist of intradermal gadolinium injection and intravenous (IV) iron contrast agent followed by MRI imaging approximately 1 week after the first session. The third session will occur at minimum eight weeks later and entail intra-articular ICG injection in order to evaluate drainage via the lymphatics. The MCP joints will be identified in the non-dominant hand and injected with ICG. Approximately one week later, the fourth session will compromise of intra-articular gadolinium injection and IV iron contrast to confirm lymphatic drainage. The MCP joints of the non-dominant hand will again be identified and injected with gadolinium.

Drug: Indocyanine Green; Device: MultiSpectral Imaging System

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

NIR-ICG MRL

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

NIR-ICG MRL

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 must be 18 years old or older.

You may not qualify if:

• Active systemic disorders or inflammatory conditions (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
• Known sensitivity to gadolinium
• Any history of kidney disease
• Pregnant women should not participate; pregnancy tests will not be performed.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Kenney HM, Dieudonne G, Yee S, Maki JH, Wood RW, Schwarz EM, Ritchlin CT, Rahimi H. Near-Infrared Imaging of Indocyanine Green Identifies Novel Routes of Lymphatic Drainage from Metacarpophalangeal Joints in Healthy Human Hands. Lymphat Res Biol. 2023 Aug;21(4):388-395. doi: 10.1089/lrb.2022.0026. Epub 2023 Feb 20.

  PMID: 36809077 DERIVED

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

• Homaira Rahimi, MD, MTR

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 6, 2019
• Study Start: December 15, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)