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

Not Applicable

Completed

• Conditions: Malignant Melanoma
• Interventions: Procedure: Neurofilament light protein measurement in Isolated limb perfused patients

• Registration Number: NCT04460053
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-12
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2020-07-05
• Study First Posted: 2020-07-07
• Primary Completion: 2020-09-18
• Study Completion: 2020-10-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Patient scheduled for treatment with isolated limb perfusion
2. Age over 18 years
3. Signed informed consent

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neurofilament light protein measurement	Neurofilament light protein measurement in Isolated limb perfused patients	Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.

Primary Outcome Measures

Name	Time	Method
Neurofilament light protein measurement in peripheral blood	4 weeks postoperatively	Neurofilament light protein

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden