Clinical trial NCT04460053: Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
Official title: A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Melanoma
Keywords: toxicity
biomarker
Neurofilament Light protein
In-transit metastasis
Hyperthermic isolated limb perfusion
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2020-07-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective feasibility trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Neurofilament light protein measurement in peripheral blood
timeFrame: 1 day postoperatively
measure: Neurofilament light protein measurement in peripheral blood
timeFrame: 3 days postoperatively
measure: Neurofilament light protein measurement in peripheral blood
timeFrame: 4 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital, Department of Sugery
name: Roger Olofsson Bagge
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2024 Nov;39(8):1657-1666. doi: 10.1177/02676591231213506. Epub 2023 Nov 7.
citation: Corderfeldt Keiller A, Holmen A, Hansson C, Ricksten SE, Bragadottir G, Olofsson Bagge R. Non-invasive and invasive measurement of skeletal muscular oxygenation during isolated limb perfusion. Perfusion. 2023 Jul;38(5):1019-1028. doi: 10.1177/02676591221093201. Epub 2022 May 16.