Clinical trial NCT04046146: Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
Official title: Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Healthy Volunteers
Lymphatic Transport
Imaging
Indocyanine Green
Gadolinium
ICG
GAD
NIR-ICG
rhuematoid arthritis
NIR
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent.
* Subjects must be 18 years old or older.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Manual lymphatic vessel counts via assessment of 2D images of NIR-ICG compared to MRI. Unit of measure: # lymphatic vessels/hand
timeFrame: 12 months
measure: Lymphatic contraction rate measured via NIR ICG camera. Unit of measure: # contraction/minute
timeFrame: 12 months
measure: ICG clearance measured from hand using NIR ICG images. Unit of measure: (% difference Visit 1 from Visit 2)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Homaira Rahimi, MD, MTR
role: PRINCIPAL_INVESTIGATOR
References: