Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

Study Overview
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Brief Summary
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A prospective feasibility trial initially including 10 patients to investigate if Neurofilament light protein can be detected in peripheral blood in patients undergoing Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive biomarker for neurotoxicity after isolated limb perfusion.

Detailed Description
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In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of the fact that a relatively mild hyperthermic temperature is used which should be well tolerated by the nerves and other normal tissues in the limbs. It seems probable that the neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity combined with a local effect of a high tourniquet pressure that is used to isolate the blood flow. Prevention of regional and systemic toxicity is essential for improving the outcome after the procedure. It is known that both higher doses of melphalan, higher temperatures and longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading system for the reaction of the normal tissues after ILP and the grading is used as a routine in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid (CSF) during axonal damage and has been shown to be elevated in different forms of dementia. An NfL assay sensitive enough to measure NfL in blood was recently developed. Its concentration reflects axonal injury in both central and peripheral nervous system disorders.The primary aim of this study is to investigate the possibility to measure neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.

Official Title
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A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

Conditions
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Malignant Melanoma

Intervention / Treatment
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* Procedure: Neurofilament light protein measurement in Isolated limb perfused patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for treatment with isolated limb perfusion Age over 18 years Signed informed consent Exclusion Criteria: None

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective feasibility trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofilament light protein measurement<br>Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively. | Procedure: Neurofilament light protein measurement in Isolated limb perfused patients<br>* A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurofilament light protein measurement in peripheral blood | Neurofilament light protein | 1 day postoperatively | 
| Neurofilament light protein measurement in peripheral blood | Neurofilament light protein | 3 days postoperatively | 
| Neurofilament light protein measurement in peripheral blood | Neurofilament light protein | 4 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toxicity, biomarker, Neurofilament Light protein, In-transit metastasis, Hyperthermic isolated limb perfusion