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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2020-10-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma

NCT00001296

Melanoma

COMPLETED PHASE3

Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

NCT01106040

Breast Cancer Melanoma

COMPLETED PHASE3

Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment

NCT01920516

Metastatic Melanoma

UNKNOWN

Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

NCT04812470

Metastatic Uveal Melanoma Metastatic Cutaneous Melanoma

COMPLETED PHASE1

Evaluating the Effect of Nivolumab for Patients With In-transit Metastases Treated With Isolated Limb Perfusion

NCT03685890

Melanoma In-Transit Metastasis

RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective feasibility trial

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neurofilament light protein measurement

Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.

Group Type EXPERIMENTAL

Neurofilament light protein measurement in Isolated limb perfused patients

Intervention Type PROCEDURE

A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE