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Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport (NIR-ICG MRL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046146
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Homaira Rahimi, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Indocyanine Green Device: MultiSpectral Imaging System Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Near InfraRed Fluorescence Using Indocyanine Green and Magnetic Resonance Lymphography of Lymphatic Transport
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NIR-ICG MRL
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
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

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.
Other Name: MSImager




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

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

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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046146


Contacts
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Contact: Dustina Holt, MPH 585-273-5374 dustina_holt@urmc.rochester.edu
Contact: Amy Wielgosz, RN 585-275-1035 amy_wielgosz@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Amy Wielgosz, RN    585-275-1035    amy_wielgosz@urmc.rochester.edu   
Principal Investigator: Homaira Rahimi, MD         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Homaira Rahimi, MD, MTR University of Rochester

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Responsible Party: Homaira Rahimi, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT04046146    
Other Study ID Numbers: STUDY3891
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Homaira Rahimi, University of Rochester:
Healthy Volunteers
Lymphatic Transport
Imaging
Indocyanine Green
Gadolinium
ICG
GAD
NIR-ICG
rhuematoid arthritis
NIR
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases