Dynamic Contrast-Enhanced Fluorescence Arthroscopy of Meniscus Pilot

Study Overview
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Brief Summary
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Single-center pilot prospective observational study to determine feasibility of assessing meniscal tissue vascularity using dynamic contrast-enhanced fluorescence arthroscopy

Detailed Description
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The purpose of this pilot study is to determine whether it is possible to translate the dynamic contrast-enhanced fluorescence imaging methods we have been using to assess bone perfusion in orthopaedic trauma patients to the field of arthroscopic surgery. In other words, it is the development of dynamic contrast-enhanced fluorescence arthroscopy. While fluorescence arthroscopes are available, there are several challenges associated with minimally invasive procedures compared with wide field imaging, and this pilot study will help determine whether these can be overcome. They are mainly to do with motion artifacts caused by the non-fixed position of the scope during wash-in/wash-out of the dye, and the use of an arthroscopic pump to pressurize the fluid in the surgical cavity. The long-term goal of this work is to use dynamic contrast-enhanced fluorescence arthroscopy for the assessment of vascularity of meniscal tissue arthroscopically to determine potential healing capacity using dynamic contrast-enhanced fluorescence imaging.

Official Title
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Single-center Pilot Prospective Observational Study to Determine Feasibility of Assessing Meniscal Tissue Vascularity Using Dynamic Contrast-enhanced Fluorescence Arthroscopy

Conditions
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Knee Injuries

Intervention / Treatment
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* Procedure: Perfusion with Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older. Meniscal tear based on MRI or preoperative assessment Provision of informed consent. Exclusion Criteria: Inability of patient to provide informed consent Iodine allergy. Evidence of septic arthritis of the proposed surgical joint. Burns. Incarceration. Expected survival of less than 90 days. Problems, in the judgment of study personnel, with maintaining follow-up with the patient. Pregnant or Breastfeeding Women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with a meniscal tear requiring surgery<br>Patients will be administered Food and Drug Administration (FDA) approved Indocyanine green (ICG) through intravenous injection and imaged by a FDA approved surgical fluorescence imaging device. Both ICG fluorescence and the imaging system have been used for routine clinical practice for many years. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to meniscal perfusion can be captured by an arthroscopic imaging system. | Procedure: Perfusion with Indocyanine green<br>* Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of meniscal blood supply using Indocyanine green (ICG) | The primary study outcome is to measure meniscal blood flow in patients during surgery. | Baseline, up to 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure setting (mm Hg) required for optimal visualization of ICG-based fluorescence. | assess the impact of arthroscopic pump pressure on the visualization of ICG-based dynamic contrast-enhanced fluorescence in the joint and to develop parameters around effect of the pump. | Baseline, up to 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meniscus, Indocyanine green, fluorescence, imaging