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NCT04460053 Clinical Trial

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

Malignant Melanoma Clinical Trial

— ILP-NfL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04460053
Other study ID # ILP-NfL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 12, 2019
Est. completion date October 25, 2020

Study information
Verified date April 2024
Source Vastra Gotaland Region
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date October 25, 2020
Est. primary completion date September 18, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Neurofilament light protein measurement in Isolated limb perfused patients
A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.

Locations
Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Corderfeldt Keiller A, Axelsson M, Bragadottir G, Blennow K, Zetterberg H, Olofsson Bagge R. A prospective feasibility trial exploring novel biomarkers for neurotoxicity after isolated limb perfusion. Perfusion. 2023 Nov 7:2676591231213506. doi: 10.1177/0 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Neurofilament light protein measurement in peripheral blood Neurofilament light protein 1 day postoperatively
Primary Neurofilament light protein measurement in peripheral blood Neurofilament light protein 3 days postoperatively
Primary Neurofilament light protein measurement in peripheral blood Neurofilament light protein 4 weeks postoperatively
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