Evaluation of Neuroma Perfusion With Indocyanine Green Fluorescence Angiography

Study Overview
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Brief Summary
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The purpose of this study is to characterize the perfusion of neuromas using indocyanine green fluorescence angiography

Detailed Description
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Neuromas represent the frustrated regeneration of injured nerve axons encased in a bulbous scar. Symptomatic neuromas are particularly problematic in patients with amputations. Targeted Muscle Reinnervation is a novel surgical approach to neuroma treatment, resulting in improved residual limb pain in amputees. Nevertheless, a subset of Targeted Muscle Reinnervation patients achieve inadequate relief. Incomplete neuroma excision may be of particular concern in such cases, as failure to completely excise the neuroma risks leaving a scarred proximal nerve stump behind. Despite the critical importance of complete neuroma excision, there is no clear definition of a neuroma's zone of injury. Indeed, intraoperatively determining where to cut a nerve to ensure accurate and complete excision of a neuroma at the time of reconstruction or repair is an unsolved problem in peripheral nerve surgery. The proposed research aims to characterize the perfusion of neuromas using fluorescence angiography. Specifically, we will test the hypothesis that intravascular indocyanine green (ICG) renders visible the perturbations in nerve perfusion associated with neuromas, and that these altered perfusion patterns correlate with the nerve's zone of injury as identified by histopathology. Ultimately, indocyanine green (ICG) fluorescence angiography may facilitate intraoperative decision-making at the time of neuroma excision.

Official Title
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Evaluation of Neuroma Perfusion With Indocyanine Green Fluorescence Angiography

Conditions
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Neuroma, Neuroma Amputation, Neuroma of Upper Limb, Neuroma of Lower Limb

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Clinical diagnosis of neuroma Scheduled elective surgery for neuroma excision Exclusion Criteria: Minors, or age < 18 years old at the time of surgery Unable to provide written, informed consent Prisoners and decision-impaired individuals Pregnant or lactating women History of allergy to indocyanine green History of allergy to iodides History of allergic asthma History of hepatic failure History of renal failure Patients in whom the planned surgical incision/approach does not include excision of the neuroma Patients in whom adequate surgical exposure of the neuroma is unable to be obtained, as determined intraoperatively at the time of surgery by the Investigator or Co-Investigators Any subject who, at the discretion of the Investigator or Co-Investigators, is not suitable for inclusion in the study

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuroma ICG<br>Subjects will receive Intravenous ICG to generate a Fluorescence Angiogram of the Neuroma | Drug: Indocyanine green<br>* Intravenous administration of indocyanine green followed by fluorescence angiography imaging of the neuroma<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroma ICG Fluorescence Angiogram | Fluorescence Angiogram of the Neuroma | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine Green, Neuroma, Targeted Muscle Reinnervation, Regenerative Peripheral Nerve Interface, Nerve Repair, Fluorescence Angiography