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NIR Fluorescence Imaging of Lymphatic Transport Using ICG (NIR-ICG)

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: NCT02680067
Recruitment Status : Recruiting
First Posted : February 11, 2016
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Christopher Ritchlin, University of Rochester

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE February 11, 2016
Last Update Posted Date April 30, 2020
Actual Study Start Date  ICMJE December 8, 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Contraction Rate [ Time Frame: 36 months ]
The contraction rate is measured as lymphatic vessel contractions/min in the dominant lymphatic vessel efferent to the injection site using the MultiSpectral Imaging System (MSImager) that captures real time movies. The MSImager software analyses the signal intensity to determine the contraction rate.
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Contraction Rate [ Time Frame: 12 months ]
The contraction rate is measured as lymphatic vessel contractions/min in the dominant lymphatic vessel efferent to the injection site using the MultiSpectral Imaging System (MSImager) that captures real time movies. The MSImager software analyses the signal intensity to determine the contraction rate.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Lymphatic Pressure [ Time Frame: 36 months ]
The lymphatic pressure is measured using a transparent cuff and the Multispectral Imaging System to determine indirect lymphatic pressure and recorded as mm Hg.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2016)
Lymphatic Pressure [ Time Frame: 12 months ]
The lymphatic pressure is measured using a transparent cuff and the Multispectral Imaging System to determine indirect lymphatic pressure and recorded as mm Hg.
Current Other Pre-specified Outcome Measures
 (submitted: February 15, 2018)
  • Clearance [ Time Frame: 36 months ]
    The change in Indocyanine Green signal intensity (arbitrary units) over time is measured by observing the fluorescence using the Multispectral Imaging System. The MSImager software analyses the signal intensity.
  • Lymphatic Speed [ Time Frame: 36 months ]
    Speed with which an Indocyanine Green bolus moves through a lymphatic vessel recorded as mm -sec-1 using the Multispectral Imaging System. The MSImager software analyses the signal speed.
Original Other Pre-specified Outcome Measures
 (submitted: February 8, 2016)
  • Clearance [ Time Frame: 12 months ]
    The change in Indocyanine Green signal intensity (arbitrary units) over time is measured by observing the fluorescence using the Multispectral Imaging System. The MSImager software analyses the signal intensity.
  • Lymphatic Speed [ Time Frame: 12 months ]
    Speed with which an Indocyanine Green bolus moves through a lymphatic vessel recorded as mm -sec-1 using the Multispectral Imaging System. The MSImager software analyses the signal speed.
 
Descriptive Information
Brief Title  ICMJE NIR Fluorescence Imaging of Lymphatic Transport Using ICG
Official Title  ICMJE Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green
Brief Summary In this phase 1 study, the lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy individuals using a MultiSpectral Imaging System (MSImager).
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. The use of lasers imposes a risk of eye injury that requires protective eyewear. To address the risk of laser-induced injury, an imaging system was developed by Drs. Ronald Wood and Jay Reeder in a collaborative effort at the University of Rochester. In place of a laser, this system utilizes a tungsten-halogen lamp fitted with a bandpass filter and a multispectral camera for real-time image acquisition and display. This phase 1 study will examine the validity and reliability of this instrument to measure lymphatic transport, contractions, and pressure in the arms of healthy research subjects and establish baseline parameters for subsequent evaluation of rheumatoid arthritis patients in later studies. Indocyanine Green is a dye that has been used clinically for over 50 years to evaluate hepatic clearance, cardiovascular function testing, and retinal angiography. Indocyanine Green has typically been administered intravenously at concentrations of 2.5 mg/ml at total doses of 25 mg in adults. In this study, intradermal administration of micrograms of Indocyanine Green will be used to establish useful dose ranges and concentrations. The dosage regimen for this study is based on prior demonstrations in published articles of successful noninvasive imaging of lymphatic contractions after intradermal administration of microgram amounts of Indocyanine Green.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Healthy individuals and subjects that have rheumatoid arthritis may participate in the developmental arm. Healthy individuals may participate in the clearance arm. There will be no randomization.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Developmental arm - Healthy or rheumatoid arthritis subjects
    Subjects in the developmental arm will have a minimum of two study visits to determine the optimal conditions for visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities may be performed after the ICG fluorescence is observed. The exam will help identify the location of the lymphatic vessels and nodes in the areas fluoresced.
    Interventions:
    • Drug: Indocyanine Green
    • Device: MultiSpectral Imaging System
  • Experimental: Clearance arm - Healthy individuals
    Subjects in the clearance arm will have an initial study visit that involves injections of 0.1 mg/ml of Indocyanine Green (ICG) intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). Follow up imaging sessions will occur weekly for three weeks for a minimum of four study visits total.
    Intervention: Drug: Indocyanine Green
Publications * Rahimi H, Bell R, Bouta EM, Wood RW, Xing L, Ritchlin CT, Schwarz EM. Lymphatic imaging to assess rheumatoid flare: mechanistic insights and biomarker potential. Arthritis Res Ther. 2016 Sep 1;18:194. doi: 10.1186/s13075-016-1092-0. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2016)
20
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to provide written informed consent
  • Subjects can be either gender but must be at least 18 years old.
  • Rheumatoid arthritis subjects may fulfill 2010 American College of Rheumatology criteria.
  • Active rheumatoid arthritis subjects, with at least 2 tender or swollen joints.
  • Subjects participating in the clearance arm of the study must not have ICG injections for at least 10 weeks.

Exclusion Criteria:

  • Individuals with active systemic disorders or inflammatory conditions other than rheumatoid arthritis, (such as 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
  • Pregnant women should not participate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dustina M Holt, MPH 585-273-5374 Dustina_Holt@urmc.rochester.edu
Contact: Debbie Campbell, RN 585-275-1635 Debbie_Campbell@urmc.rochester.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02680067
Other Study ID Numbers  ICMJE RSRB 54038
R01AR056702 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Christopher Ritchlin, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Christopher Ritchlin, MD/MPH University of Rochester
PRS Account University of Rochester
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP