University of Rochester
Rochester, New York, 14642, United States
NCT Number: NCT04046146
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.
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Notify Me18 year–89 year
All sexes
Interventional
Phase 1
Rochester, New York, 14642, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: ICG, IC-Green, 17478-701-02
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.
Other names: MSImager
Time frame: 12 months
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.
Time frame: 12 months
Images collected from NIR scanning sessions will be analyzed to determine lymphatic contraction rate by identifying number of contractions per minute.
Time frame: 12 months
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.
University of Rochester
Other
Acronym: NIR-ICG MRL
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