NCT04046146

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Detailed description

Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. Efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. Published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of Indocyanine Green using laser-induced fluorescence. We recently demonstrated the feasibility of NIR imaging to quantify lymphatic drainage in the hands, wrists and forearms of healthy volunteers following intradermal web space ICG injection into the hand . To establish this emerging technology as a valid clinical outcome measure, however, we must address two major questions that confound interpretation of the imaging results: 1) are the ICG filled vessels lymphatic vessels and/or small veins?; and 2) does NIR-ICG imaging following web space injection fully capture lymphatic flow from the metacarpophalangeal (MCP) joints that are most commonly involved in RA? To answer these questions, healthy patients will be recruited to have intradermal and intra-articular injections of ICG and gadolinium followed by an imaging sessions (NIR or magnetic resonance imaging) to measure lymphatic contraction rates and flow.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Indocyanine Green	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.
DEVICE	MultiSpectral Imaging System	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.

Timeline

• Start date: 2019-12-15
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2019-08-06
• Last updated: 2020-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study